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Safe Practices For Sausage Production: Distance Learning Course Manual
Safe Practices For Sausage Production: Distance Learning Course Manual
Sausage Production
Distance Learning Course Manual
Sponsored by:
Summary ……………………………………………………………………………..…. 39
Glossary ………………………………………………………………………………... 42
Appendices……………………………………………………………………………… 60
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"…even kids with chicken pox, love hotdogs…" (Armor hot dog
Introduction jingle)
History of Sausages The process of preserving meats by stuffing salted, chopped meats
flavored with spices into animal casings dates back thousands of
years, to the ancient Greeks and Romans, and earlier. The word
“sausage” is derived from the Latin word “salsus”, which means
salted, or preserved by salting. Sausages and sausage products
have since evolved into a wide variety of flavors, textures, and
shapes resulting from variations in ingredients and manufacturing
processes.
Overview of the Safe This manual is one component of a USDA FSIS tele-course on the
Practices in Sausage safety issues associated with the production of sausage products.
Production Course and The manual is designed to supplement the information presented
Manual within the course, and provide you with a lasting reference that you
can review at a later date.
What information is Throughout this manual, we will cover a range of issues related to
covered in this sausage production, including;
manual? - the sausage production process,
- safety and sanitation issues at each stage of the
process, and
- pathogens of concern to sausage makers.
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Course Objectives Once you have completed this course, you will be able to:
Purpose of this course This program is intended to provide the retail food inspector some
and manual insight into the processes used by food processors to produce the
many products distributed for retail sale. Today, however, many
grocery stores, meat markets, and other retail food establishments
are producing their own sausage products. Many of the principles
that apply to large food processors also apply to retail operations.
Therefore, our primary purpose is to provide some background
information to the retail inspector who encounters these sausage
processes. This course will review the sausage production process,
identify critical food safety areas within the process, and review the
procedures that should be followed to ensure that only safe
products are produced. We have attempted to target the
information presented to the retail inspector.
State food laws often can not provide detailed proscriptive guidance
for the diverse processes used in sausage manufacturing. Often
State and local inspectors rely on compliance with general good
manufacturing practices (GMP), which can cause conflicts because
GMPs are open to subjective interpretation.
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information can also be useful when evaluating the scientific
soundness of a retail establishment’s HACCP plan. As with any
type of guidance from outside agencies, inspectors should discuss
with their supervisors how this information could appropriately be
used in their regulatory programs.
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Several categories of sausage products are typically consumed in
Examples of the U.S., each with specific production processes and storage
Sausage requirements. These categories include fresh sausages, such as
fresh pork sausages, cooked sausages, such as frankfurters, and dry
Products sausages, such as meat sticks.
Fresh Pork Sausage Fresh pork sausages are produced from selected cuts of fresh and
sometimes frozen pork, pork trimmings, and water, along with
seasonings. Since fresh sausages do not contain curing agents, and
are neither cooked nor smoked, they require refrigeration. These
types of sausages must be thoroughly cooked before serving.
Meat Stick Meat snack sticks are produced using controlled, bacterially-induced
fermentation to preserve the meat and impart a special flavor, along
with a long drying period to cure and preserve the meat. These
processes produce a shelf-stable product.
In this course, you will learn about the production process and
production requirements for each of these categories of sausages.
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In this section, you will go over the main steps that are utilized to
Producing produce standard sausage products, including Fresh Sausages,
Sausages Cooked and Smoked Sausages, and Dry Sausages.
Fresh Sausages Fresh Sausages are made from selected cuts of fresh and
sometimes frozen meats. Fresh sausages are not allowed to
contain curing agents [i.e., sodium or potassium nitrites, nitrates, or
salt in sufficient quantities to preserve the product] and are not
cooked. Fresh sausages are usually seasoned, and have limited
water content. These types of sausages require refrigerated
storage, and must be thoroughly cooked before serving.
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breakfast sausage, Italian sausage, and fresh chorizo sausages.
Grinding Meat In this section we’ll briefly review each stage of the production
Ingredients process for creating most types of fresh sausages. These steps are
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also used to create other types of sausages.
Adding Non-Meat There are many non-meat ingredients that are essential to the
Ingredients sausage making process. These non-meat ingredients stabilize the
mixture, and add specific characteristics and flavors to the final
product. Ingredients used in fresh sausage include water, salt, and
antioxidants, along with traditional spices, seasonings, and
flavorings.
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The amount of non-meat ingredients, such as spices, is determined
by the overall weight of the product mixture. Since the amounts of
these ingredients must be carefully controlled, and measuring very
small amounts of numerous specific ingredients within a
manufacturing environment is often not practical, many
manufacturers use a commercially pre-measured and packaged
mix of these ingredients.
Blending Manufacturers carefully control the blending of the meat and non-
meat ingredients to create the desired characteristics for a specific
sausage formulation.
Stuffing After the blending is complete, the blended ingredients may be bulk
packaged, or they many be extruded into a casing. This process is
called stuffing. Fresh sausages are typically stuffed into natural
animal casings. Natural casings used for fresh sausage are derived
from the small intestines of sheep. To create the natural casings,
the casing processor washes, scrapes, and treats the casings,
grades the casings for size and condition, then salts, packages, and
ships the casings in brine or propylene glycol (for preservation) to
the sausage manufacturer.
The Stuffing Process The stuffing process can be accomplished in a number of ways.
Natural casings are typically flushed with water, and the mixture is
injected into the casing at a pressure that is sufficient to fill the
casing without leaving any air pockets, and without tearing the
casing. The stuffing process is also sometimes conducted at lower
temperatures (<35-380F) to minimize fat smearing on the casing.
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output of the grinder directly into the casing. Larger manufacturers
may use air or water-piston type automatic stuffers.
Packaging The fresh sausage product is sometimes packaged for sale to the
customer. The product may be wrapped in a gas impermeable
plastic, and placed into refrigerated storage or display. The specific
packaging will vary according to the needs of the end user,
however, the processor must follow hygienic standards when
packaging any sausage product to avoid contaminating the product.
Often retail fresh sausage is tray packed.
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Cooked and smoked sausages account for approximately 85% of all
Cooked and sausages produced today. Typical cooked sausages, like
Smoked frankfurters or bologna, are made from fresh or frozen meat that is
cured during processing, fully cooked, and smoked. These types of
Sausages sausages are perishable and must be refrigerated until time of
consumption, or they expire. These sausages have additional
flavors that are imparted through the addition of nitrites and nitrates,
and via various cooking and smoking processes.
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inside of an impervious casing or steel mold, often inside a steam
cabinet or water bath instead of a smokehouse. The impervious
casing causes these types of cooked sausage to retain all moisture
during cooking, so the manufacturer must closely control the
amount of water during formulation to ensure that it does not
exceed the 10% limit.
§ Smoking
§ Cooking
§ Showering
§ Chilling
§ Peeling
Cooked and smoked sausages start out very similar to the fresh
sausages. Raw meat ingredients are ground and blended with non-
meat ingredients. A bowl chopper (known in the industry as a silent
cutter) is sometimes used to simultaneously blend and chop the
mixture. The bowl chopper passes a series of knives through the
mixture, usually resulting in an increase in temperature due to
friction. A combination of ice and water is often added to the
mixture to control the temperature and facilitate the grinding and
blending process.
Meat Ingredients Skeletal beef muscle tissue from bull, cow, and shank meat have
the highest binding capabilities. Intermediate or medium binding
Binding Ability meats include head meat, cheek meat, and lean pork trimmings.
Low binding meats contain higher levels of fat, and are typically
non-skeletal meats, such as jowls, fat, briskets, hearts, and tongue
trimmings.
Non-meat proteins, such as cereal flours and non-fat dry milk must
also be uniformly distributed, however, these ingredients usually are
added last, since they absorb water that is required for protein
emulsification
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Emulsification Some manufacturers run the mixture through an emulsifier after the
blending stage to further reduce the size of the meat particles, to
achieve a very fine texture. In the emulsification process, fat,
protein, salt and water are mixed, and combined into a semi-fluid
emulsion. The meat muscle protein, called "myosin", is solubilized
or released from the muscle fibers by contact with salt. The
solubilized protein and water combine and surround the fat
globules, and hold the fat particles in a disbursed suspension within
the mixture, along with spices and seasonings.
Stuffing Cooked and smoked sausages are stuffed into casings in a process
similar to fresh sausages, however, manufacturers of these
products utilize a wider range of casing materials.
Natural casings used for cooked and smoked sausages are derived
from the stomach, and intestines of hogs, the intestines, bung and
bladder of cattle, and the intestines of sheep. They are edible, and
allow smoke and moisture to permeate the sausage during
processing.
Hog middles are produced from the large intestine, and are used for
Italian sausages and liver sausages. The small intestine is utilized
to create small hog casings that are utilized for smaller diameter
products, such as Polish sausage, smoked pork sausage, and
bratwurst. And hog bladders are used as casings for minced
luncheon meats.
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Sheep casings are generally made from the small intestine. These
small diameter casings are typically used for frankfurters and pork
sausages.
Beef rounds are casings that are produced from the small intestine,
and are used for products such as bologna and mettwurst. Beef
middles are larger casings created from the large intestine, and are
used to produce sausages such as bologna, cervelat and salami.
Sometimes manufacturers use casings that are not derived from the
same type of meat as the main meat ingredients of the sausage.
For example, a manufacturer can use a pork casing on a beef and
lamb combination sausage. Currently, manufacturers are not
required to disclose that the natural casing is not derived from the
same livestock species as the sausage itself.
These types of lower strength casings are typically used for smaller
diameter products.
Synthetic and Synthetic or artificial casings are made from special papers
Cellulose Casings impregnated with cellulose, saran casings made from synthetic
plastics, and hydro-cellulose casings made from regenerated
cellulose. Cellulose casings are created from dissolved fibers
extracted from cotton seeds or paper pulp. Each of these types of
casings are available in a wide range of sizes and characteristics
and are easy to handle, however, these types of casings are not
edible and must be removed from the sausage prior to
consumption. Artificial casings provide high strength and are
available with excellent permeability to moisture and smoke, or as
impermeable casings for use in producing water-cooked products
such as braunschweiger.
Smoking Smoking is used to dry and cure the meat, and impart flavors and
aroma to the final product. Smoking was traditionally important
because it inhibited bacterial growth on the finished product,
however, in modern times we rely on refrigeration to inhibit
bacteria. A smoke generator creates natural smoke via a carefully
controlled burning of hardwood sawdust, wood chips, or logs.
Hickory is the most popular wood used for smoking, but other
hardwoods and fruitwoods are also used. Coniferous trees such
as pine are unacceptable because they contain resins, smoke from
that type of wood has a high tar content and imparts a bitter flavor.
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acids, carbonyls, phenolics, and polycyclic hydrocarbons. The
amount of these materials that is deposited on the product surface
is controlled by varying the density of the smoke, the duration of
the smoking cycle, and the air velocity within the smoking
chamber.
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The cooking process is carefully controlled to ensure that the
product reaches a specific internal temperature for a defined period
of time. Thermocouples are used to monitor the temperature
during the cooking process.
Showering / After the smoking and cooking phase, the sausage product
undergoes a cold water shower. Showering maintains the product
Chilling humidity and stops the cooking process by reducing the product
temperature as quickly as possible. Showering also helps to
prevent shrinkage and wrinkling of the product casing.
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Salts have traditionally been used to help preserve sausages.
Eventually, producers learned that nitrates and nitrites in the salts
were essential to the curing process. Manufacturers of dry and
semi-dry sausages use a curing agent consisting of salt and nitrates
and/or nitrites. Approved antioxidants may also be added to protect
flavor and prevent rancidity, and are limited to .003% individually, or
0.006% in combination with other antioxidants. These ingredients
must be uniformly distributed throughout the mixture to achieve the
maximum microbiological stability.
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almost always smoked and cooked before drying. Dry sausages like
pepperoni are rarely smoked, and may or may not be cooked.
Today, some establishments choose to heat treat these dry
sausages as a critical step designed to eliminate E.coli. A moist
heat process may be used for some products. This process utilizes
a sealed oven or steam injection to raise the heat and relative
humidity to a meet a specific temperature/time requirement
sufficient to eliminate pathogens (e.g., 1300F minimum internal
temperature for 121 minutes, or 1410F minimum internal
temperature for 10 minutes). [Processors should consult the FSIS
regulations 9 CFR 318.10 and the Cattlemen’s Blue Ribbon book for
processes designed to control E. coli.] The product is then sent on
to the drying stage of the process.
Drying Process The drying process is a critical step in ensuring product safety. FSIS
requires that these products undergo a carefully controlled and
monitored air drying process that cures the product by removing
moisture from the product. Pork-containing products must be
treated to destroy trichinae (see 9 CFR 318.10). Sausages not
containing pork have no such requirement.
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vary depending on the specific facility operation and the
specifications desired for the final product. For example, pepperoni
is required to maintain an MPR of 1.6:1, indicating a requirement of
1.6 parts moisture to one part protein. Genoa salami should have
an MPR of 2.3:1, and all other dry sausages an MPR of 1.9:1.
Inspectors may sample the products to determine compliance with
the specified MPR.
This chart identifies the FSIS MPR policy standards for some dry
and semi-dry sausage products. These standards are not in the
regulations, they are contained in the FSIS Food Standards and
Labeling Policy Book.
FSIS Policy Standards, Moisture-Protein Ratio (MPR) for Dry and Semi-Dry Sausages
Although these are the FSIS standards for dry and semi-dry
sausages, they can provide a basis for State and local decisions
about whether specific processes are adequately designed to
ensure product safety.
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In this section we'll take a brief look at some of the standard
Sausage equipment and processes that are used to produce sausages, along
Production with the safety issues that should be addressed for each item.
There are many different manufactures of equipment, and you will
Equipment see many variations of these basic equipment types.
Grinders Grinders are used to chop the meat ingredients into small pieces.
Meat is fed from a hopper, passed along a cylinder with an auger or
worm, to a perforated plate where it is sliced away by a series of
revolving blades. The friction produces a rise in temperature, which
potentially could result in bacterial growth if not controlled.
Blenders Blenders use screw-like agitators to mix the solid ground meat
mixture with any additional non-meat ingredients to create a
consistent distribution of all ingredients within the formulation.
Bowl Choppers Bowl Choppers (silent cutters) utilize a series of knives that chop
and mix the product formulation. The friction of the knives passing
through the meat will raise the temperature of the meat mixture.
Stuffers Stuffers are used to extrude the sausage formulation into the
casing. The ground mixture is fed from a hopper into a reservoir
and forced through a nozzle into the casing.
Smokehouses Smokehouses are heated drying rooms into which the manufacturer
injects smoke. The smoke adds specific flavors to the product, and
helps dry and cure the product. The smokehouse may also serve
as a controlled thermal processing chamber, and is used to dry,
smoke, heat, cool, and add humidity to the product.
Smokehouse Smokehouse recorders are devices that monitor and track the
Recorders smoking duration for each sausage production run. The smoking
process must be carefully controlled to ensure a consistent level of
product quality.
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blade that slices the casing, touching each sausage that goes by,
this is an ideal environment for bacteria, especially Listeria. Peelers
must be carefully monitored because of the potential for bacterial
growth.
Greenrooms / Greenrooms and drying rooms are used to cure and dry the
Drying Rooms sausage product. In some cases, the environment is designed to
support controlled, bacterially-induced fermentation processes that
are used to cure the product and impart special flavorings.
Packaging Equipment The final sausage product is often packaged prior to sale.
Packaging typically consists of wrapping the product in plastic film.
The packaging protects the product from cross contamination, and
helps to retard spoilage caused by contact with the air.
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In this section, we will go over the types of ingredients that
Ingredients in are used to produce standard sausage products, including
Sausages fresh sausages, cooked and smoked sausages, and dry
sausages. Each type of sausage uses a different mix of
ingredients.
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inspected meat should be re-inspected to ensure that it has
not become contaminated during transit.
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Cooked sausage manufacturers are allowed to vary the
amount of added water according to the amount of fat. The
maximum fat content is limited to 30%, and the amount of fat
and water combined is limited to 40%, so the manufacturer
can increase water to substitute for reduced fat. Typically,
the amount of naturally occurring water is determined by
computing four times the protein content. Any moisture
above that amount is considered added water.
Curing Agents Curing agents such as nitrite and nitrate have traditionally
been used in sausage formulations, originally as a
contaminant present in salts, and later added intentionally in
the form of saltpeter. Nitrites provide bacteriostatic and
antioxidant properties, and improve the taste and color of the
sausage. Nitrites help to control the growth of bacteria in
vacuum-packed products, such as frankfurters and luncheon
meats. Nitrites prevent the outgrowth of bacteria, such as
the lethal Clostridium botulinum bacterium that causes
botulism. Nitrites also inhibit the oxidation of fats in meats,
reducing the development of oxidative rancidity. Nitrites
produce the desired reactions much faster and are much
more commonly used than nitrates. The use of nitrate by
large processors is rare, because the process of converting
the nitrate into nitrite within the product is much slower and
less reliable than addition of nitrite directly.
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and clearly marked accordingly. The maximum level of these
additives that is acceptable is spelled out in the FSIS
regulations, as indicated below.
Substance Amount
Sodium or potassium nitrate 2 ¾ oz. to 100 lb. chopped meat
Sodium or potassium nitrite ¼ oz. to 100 lb. chopped meat
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Mold Inhibitors Mold is a commonly encountered problem in the production of dry
sausages. The common technique for inhibiting the growth of mold
is to dip the sausage in a mold inhibitor solution, typically 2.5
percent solution of potassium sorbate or a 3.5 percent solution of
propylparaben.
Glucono Delta Glucono Delta Lactone (GDL) is a cure accelerator that produces an
Lactone (GDL) acid tangy flavor similar to flavor resulting from natural fermentation.
It is allowed at 8 oz. to each 100 lb. of meat.
Spices, Seasonings, Spices, seasonings, and flavorings are used to add flavor to the
and Flavorings sausage, and also affect the consistency of the ground mixture.
The wide range of available spices, seasonings, and flavorings is a
primary reason for the variety available in sausages.
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• the product type and name;
• the type and amounts of meats and meat by-products in the
product;
• the type and amounts of cure agents;
• the method of formulation, such as chopping time and
emulsifying time and method;
• the type of casing and method of stuffing;
• the smoking/ cooking time and temperature, along with
expected shrinks;
• and the chilling time and expected chill shrinks.
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Batch formula
Regular Pork Trimmings (60% fat) 280.00 lb. Fresh Pork Sausage
Special Pork Trimmings (30% fat) 156.00 lb. Limitations
Water 15.00 lb. § Limited to 50% Fat or
Fresh Sausage Seasoning 9.00 lb. less
Total 460.00 lb.
§ Added Water/ice up
to 3%
The Fresh Sausage Seasoning formulation is :
§ Antioxidant amount
Salt 5 lb.
based on fat – limited
Sugar 2 lb.
to 0.01%
Black Pepper 15 oz
Sage 11 oz
Nutmeg 5.64 oz
BHA (Antioxidant) 0.36 oz
Total 9.0 lb.
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Is added water content The amount of added water and/or ice in fresh
within limits? sausage is limited to 3% of the product weight.
The inspector will use these steps to determine
the amount of water permitted in this formulation.
460 lb. (100%) First, subtract the water from the total formula
-15 lb. (3%) weight to determine the total weight minus the
445 lb. (97%) water.
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Then divide the formula weight minus the water by
the total weight without water (.97) to determine
445/.97 = 458.76 the total formulation weight with the allowed
amount of water added.
Is the type and amount Antioxidants in fresh sausage are limited to 0.01%
of antioxidant within of the total amount of fat in the product. In this
limits? example, we will assume that the target fat
amount of 40% in this formulation has been
confirmed.
460
X 0.40 The first step is to determine the weight of the fat.
184 lb. Multiply the batch weight by the fat content (40%)
Batch formula
Beef 185 lb.
Pork 225 lb.
Bacon ends and pieces 50 lb.
Water and ice 80 lb.
Rework (like product) 50 lb.
Nonfat dry milk 20 lb.
Salt 9 lb.
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Mustard (29% protein) 5 lb.
Spice mix (12% protein) 4 lb.
Erythorbic acid 4 oz.
Cure mix (8% nitrite) 12 oz.
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During a 6 month period beginning August 1998, the Center for
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Disease Control (CDC) reported at least 50 illnesses caused by
Biological Listeria monocytogenes bacterium. Six adults died, and two
Hazards of pregnant women had spontaneous abortions. The source of the
contamination was later traced via routine FSIS monitoring/sampling
Concern to to hot dogs and deli meats produced by a facility in Michigan.
Sausage Estimates of the overall magnitude of the problem are imprecise.
Makers During 1998, at least 9787 laboratory-confirmed cases of illness
related to foodborne contamination were confirmed, however, only a
fraction of the persons who experience foodborne illnesses are
believed to seek medical care, and even a smaller number to submit
laboratory specimens.
Public health laboratories around the U.S. now have the capability
to conduct molecular subtyping of pathogens present in humans
and foods using Pulsed-Field Gel Electrophoresis (PFGE)
technology, a type of “fingerprinting” that allows the agencies to link
illnesses to specific products, and trace the source of any
contaminated products to determine the cause. This is improving
the ability of public health agencies to monitor and mitigate the
effects of contaminated food products.
The microscopic size of the trichina parasite larvae (0.1 mm) makes
it difficult to identify in a typical packinghouse operation, so FSIS
requires that all pork be treated to destroy the parasite, via heating,
refrigeration, or curing.
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treatment method. A temperature of 1440F is considered fatal to all
trichinae organisms. This temperature is typically exceeded during
the cooking process, however, products that are partially cooked at
lower temperatures, such as smoked pork sausage, require
additional treatment. These products typically undergo a
formulation and curing process designed to eliminate trichinae. The
process includes controlling the size of the chopped meat in the
product, ensuring a specific salt content, and specifying the length
of time in a drying room at a specific temperature. Another form of
treatment to eliminate trichina is freezing. These treatments are
described in FSIS regulation § 318.10 and are found in the
appendix of this document.
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§ Examine how raw materials are handled before they are cooked
and determine how handling procedures might affect L.
monocytogenes levels in the product.
§ Determine the impact of rework practices on L. monocytogenes
levels in the raw product.
§ Examine product flow, processing patterns and employee
practices and determine where opportunities for cross-
contamination occur.
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§ Time/temperature of product heat processing (cooking)
§ Product temperature during packaging
§ Amount of vacuum used in packaging
§ Rate of oxygen permeability of packaging materials
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Pathogen Control in Producers of dry and semi-dry sausages must control the
Dry and Semi-dry fermentation, smoking, and drying processes to reduce any
Sausage pathogens present in the meat formulations. The pathogens of
concern in uncooked fermented sausages such as summer
sausage are Salmonella, E. coli O157:H7, Listeria monocytogenes,
Staphylococcus aureus. FSIS has recommended a 5-log reduction
of E. coli O157:H7 in fermented sausage by validation of the
process. The pH, water activity and moisture-protein ratio of the
final product can also control the other pathogens of concern,
especially for shelf-stable fermented sausage products.
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Spoilage Bacteria, yeasts, and molds present on sausage products also
contribute to spoilage once the production of the product is complete.
Spoilage produces undesirable qualities, such as a sour taste or aroma.
The most common types of spoilage occurring on sausage products
appear as sliminess, souring, and greening.
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As with any food product, proper worker hygiene, raw ingredient
Sanitation handling and storage procedures, and the final product handling
Issues and storage procedures are essential to control product
contamination by organisms that are harmful to humans. In this
section we will look at some of these sanitation issues.
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Sausage production equipment must be maintained in a clean and
sanitary condition, under conditions that minimize the potential for
growth of pathogens. Grinding, blending, and stuffing equipment
must be completely disassembled and cleaned after each use or at
least daily. And when changing to a batch of another species of
meat, the entire grinding, blending, and stuffing assembly must be
disassembled and cleaned.
And finally, the final products must be handled and stored according
to acceptable standards to minimize the opportunities for cross
contamination and spoilage.
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Pest control - Pests must be excluded from food handling areas.
The food establishment develops its own HACCP plan, which will be
unique to its processing facility and the products produced by the
facility. The first step is to assemble a HACCP team, including one
person who is HACCP-trained. Food establishments have flexibility
in how they write their HACCP plans, and each HACCP team is
required to make its own decisions on how it will apply the HACCP
system. Therefore, the inspector will see a wide variety in the
HACCP plans encountered at processing facilities.
In this section we will go over the elements of the HACCP plan, and
describe the typical implementation process.
The HACCP team must describe each food product for each
Product Description process category that is manufactured in the establishment. The
retail establishment HACCP team should reference the product
name, intended consumer, how the product is used, type of
package, shelf life, display temperature, where and how displayed,
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and labeling. Ingredients used should be identified by listing in order
of predominance.
Process Flow Diagram The HACCP team should produce a simple description of the steps
involved in the production process.
Hazard Analysis The first part of the hazard analysis is an evaluation of the
specific food process and manufacturing establishment, and
considers the effect of a wide range of factors on the safety of
the food. The potential risk and severity of each hazard is
assessed by the HACCP team, and preventative measures
are identified.
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Typical hazards along with standard control/prevention measures.
(note: B – Biological contamination, C – Chemical contamination, P – Physical contamination.)
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Freezing (Meats) X Survival of parasites due to Rapid cooling and freezing.
improper time/temperature
application, growth of
pathogens due to temperature
abuse.
Grinding X X X Contamination during Careful employee practices, careful
handling, contamination from maintenance of equipment,
lubricants, contamination from temperature control in grinding room
damaged equipment. (<500F).
Packaging X X X Contamination from Ensure that packaging materials are
packaging, contamination from protected from contamination,
damaged containers. ensure that packaging is properly
utilized to ensure adequate barrier.
Peeling X X Contamination by pathogens Ensure careful employee handling
in product accumulations, processes, do not allow product to
contamination from employee accumulate in/on equipment,
handling, contamination from maintain peeling equipment in proper
foreign materials. condition.
Receiving X X X Contamination through Product must be received in sound
damaged containers, containers, and stored at appropriate
inappropriate storage temperature.
conditions (temp/humidity),
contamination on receiving
equipment, cross-
contamination from non-food
chemicals, contamination from
extraneous materials.
Reworking X X Contamination during Proper/careful employee practices,
employee handling, proper storage temperatures.
contamination from pathogens
in improperly stored product,
contamination by foreign
materials.
Shipping X X Pathogen growth due to Product must be stored/shipped at
inadequate shipping proper temperatures, packaging
temperatures, contamination should be intact, transport vehicles
from extraneous materials or must be clean.
through damaged packages.
Thawing X Growth of pathogens due to Thawing room temperature should
improper temperatures. not exceed 500F.
Hazard Identification The HACCP team creates a list of each of the production
steps, and identifies the hazards which might occur at each
step in the process and the preventive measures which
might be used to prevent, eliminate, or reduce each hazard
to an acceptable level. All significant hazards identified in
the hazard analysis must be addressed.
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and, as a result, a food safety hazard can be prevented,
eliminated, or reduced to acceptable levels. The HACCP
plan lists the number and location of each CCP.
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that helps manufacturers control the safety of food production
processes.
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_________________________________
For more information contact:
Association of Food and Drug Officials USDA, Food Safety and Inspection Service
(AFDO) (FSIS)
P.O. Box 3425 http://www.fsis.usda.gov/index.htm
York, PA 17402
Phone: (717) 757-2888
Fax: (717) 755-8089
afdo@blazenet.net FSIS Food Safety Virtual University
http://www.foodsafety.org/afdo/ (FSVU)
http://www.fsis.usda.gov/ofo/hrds/fsvu.html
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Sausage Glossary
This Glossary describes FSIS product standards and labeling requirements for sausage
products.
Alessandri A type of dry Italian sausage. The true product name must be sown
on the packaging (i.e., "Alessandri Sausage").
Arels or D'Arles A dry sausage similar to Milano Salami and made of coarsely
chopped meat and corded "crisscross style".
Bacon and Pork Sausage product formulated with a high percentage of bacon
Sausage (usually bacon ends and pieces) with at least 20% pork.
Berliner A cooked smoked sausage usually made from coarsely cut cured
pork in large casings. When beef is used, it shall not exceed 50%
of the meat block. Pork stomachs or beef tripe are not permitted.
Berliner Blood Sausage A cooked blood sausage containing diced bacon. After cooking, it is
dried and smoked. Ham, fat, snouts and lips are not permitted.
Blood and Tongue A cooked sausage formulated with blood and some meat, including
Sausage cooked pork or beef tongues.
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Blood sausage A cooked sausage formulated with blood and some meat. Usually
contains pork skins and/or pork jowls. May also contain sweet
pickled ham fat, snouts and lips. Of the product does not contain
meat, it must be labeled "Blood pudding".
Boudin A meat sausage or pudding usually made with chicken and veal, or
chicken and pork. It should be labeled "Boudin Sausage" (if it
meets the sausage standard), or Boudin Pudding". It may contain
by-products and rice, and is usually uncured.
Bratwurst This sausage may not contain by-products, eggs, liquid milk,
vegetables, or cheese. It may contain antioxidants.
Bratwurst, cooked Chicken has been approved in cooked bratwurst when identified in
the product name. Antioxidants are not permitted.
Bratwurst, Cured Products that meet the requirements for Bratwurst but also contain
cures must be labeled "Cured Bratwurst".
Breakfast Link Sausage Regular fresh sausage which does not have to be made with pork.
Breakfast Links or The names "Breakfast Links" and Breakfast Patties" are product
Patties names that must be followed with a descriptive product name.
Acceptable without compliance with the fresh pork sausage or
breakfast sausage standard. If the names "Breakfast Links" and
Breakfast Patties" are without further qualification, the product must
meet either the fresh pork standard or the breakfast sausage
standard.
Bungs The terminal end of the large intestines of slaughtered hogs, used
as casings for stuffing some sausage products. Refers to the
cecum or blind gut when derived from cattle.
Butifarra Sausage An uncured sausage. Labeling that features the term "Butifarra"
would require an additional product name:
- Pork sausage - for products that meet the fresh pork sausage
standard.
- Fresh Sausage - for products that include by product but do not
meet the standard for pork sausage.
- Sausage - for products that are incubated or fermented.
The term Puerto Rican Style would be applicable if manufactured in
Puerto Rico.
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Buttermilk (Dried) Dried buttermilk derived from sweet cream is acceptable as an
ingredient in meat food products. Not permitted in sausage.
Cacciatore, Cacciatora A dry Italian sausage. Cacciatora is an Italian term meaning hunter
or sportsman.
Case Hardening An undesirable crust that sometimes forms on the casing of dry
sausage items, it prevents adequate drying of the affected product.
Casing, Artificial Frankfurters packaged in retail containers with the artificial casing
left on must bear a prominent statement (e.g., "remove casing
before eating") contiguous to the product name on the label.
Casing (collagen) Collagen casings are prepared from beef hides specially processed
and formed into casings. For classification purposes, they are
edible casings but are not considered natural casings.
Cecum The blind extension of the intestine that opens into the intestinal
tract at the junction of the small and large intestine.
Certified Pork Pork that has been treated for trichinae by one of the approved
methods.
Certified Trimmings Pork trimmings or pork that has been frozen to ensure destruction of
(Certified Pork) any live trichinae in the pork muscle and certified by FSIS.
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Cheesefurter A meat food product resembling a sausage which consists of a
mixture of meat and meat and cheese, The formula shall contain
sufficient cheese to characterize the product so it may be labeled
"Cheesefurter".
Chorizo The product name "Chorizo" can be used for any type of chorizo
sausage that is cooked, dry or semi-dry, cured, or fresh without any
further product name qualification. Chorizo is seasoned with
Spanish pimento and red pepper. Partially defatted pork fatty tissue
is acceptable in chorizo.
Chorizo, Fresh These products may contain vinegar. The vinegar used must have
a strength of no less than 4 grams of acetic acid per 100 cubic
centimeters (200C).
Chorizo in Lard, Canned Chorizos that are packed hot, usually in lard, and are not
canned thermally processed must have a moisture protein ratio of 1.8 : 1
and a pH of not more than 5.5. An alternative standard is a water
activity (aW) of 0.92.
Citric Acid Citric acid and salts of citric acid, when used alone or in
combination with other chemical preservatives have several
functions. It is used to help retain fresh meat color, to prolong shelf
life without preventing deterioration or spoilage, and to increase the
activity of BHA and BHT. When used, it must be declared on the
label by it's common name, and it's purpose must be indicated in
the product name (e.g., "to help preserve flavor").
Cocktail Frankfurters A small frankfurter normally about 2" long and 1/2" in diameter.
Cold Spots The area or areas within a smokehouse that are not exposed to as
much heat as the rest of the smokehouse.
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Colored Casing Colored casings on meat and poultry products which do not transfer
color to the product, but which change and give a false impression
of the true color of the product, must be labeled to indicate the
presence of the casings.
Country Style (Farm When sausage products are labeled “farm style” or “country style”
Style) sausage they must be prepared with natural spices with the exclusion of
oleoresins, essential oils, or other spice extractives. HVP, MSG and
antioxidants are permitted ingredients.
Cow A mature female bovine, usually refers to an animal that has given
birth to one or more calves.
Derma When the term “Derma” is used in the product, only natural casing
or skin must be used.
Emulsion The semi-fluid mixture of finely chopped meat, water, spices, and
curing agents that is stuffed into casings or molds and further
processed to produce a variety of sausage products. The combining
of solubilized proteins and sometimes water to form a capsule
around fat particles.
Enterotoxin A toxin that is specific for the cells of the intestinal mucus tissues.
Exotoxin A toxin formed outside the bacterial cell and found in the medium in
which the bacteria is growing.
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Extruder A mechanical device that pushes sausage emulsions or mixtures
through a tube into a casing.
Faggots A combination of beef, veal, and pork cured with salt, nitrates and
sugar. Sheep or hog casings are used and sausage is linked in
pairs, each about 6 inches long. Classed as cooked smoked
sausage.
Farm or Country Style The terms farm or country are not permitted on labeled unless the
Fresh Sausage product is produced on a farm on in the country. Most products are
labeled farm–style or country-style, indicating that the product is
produced in a similar manner to farm or country sausages.
Farmer Sausage In usually a semi-dry sausage, but may be made in dry form.
Cervelat Usually made of equal parts of pork and beef, delicately seasoned
without garlic.
Farmer Summer A special type of sausage made of beef, pork salt spices nitrite or
Sausage nitrate, and heavily smoked. It is classed as “Cervelat” and no
extenders are permitted.
Fat Cap The accumulation of unbound fat on the ends of finished sausages,
a defect usually caused by emulsion breakdown.
“Fresh”, Not Frozen” The word “Fresh” may not be used in conjunction with the product
and Similar Terms name of any cured product (e.g., corned beef, smoked cured turkey,
When Labeling Poultry and prosciutto); any canned, hermetically sealed, shelf stable, dried
Products or chemically preserved product; or any raw poultry, poultry part, or
any edible portion thereof whose internal temperature has been
below 26 degrees Fahrenheit.
Galician Sausage In this type of sausage, cured beef and pork is seasoned and
stuffed into beef rounds, then smoked at a high temperature.
Cooling is done in a blast of air which produces a wrinkled
appearance which is characteristic of Galician sausage.
Genoa or Genoa Salami These are dry sausage products with an MPR not in excess of
2.3:1. It is prepared with all pork or with a mixture of pork and a
small amount of beef. The meat is given a coarse grind and
enclosed in a natural casing. No smoke is used in its preparation.
German Sausages with Whole milk is a permitted ingredient in these types of sausage
Milk products when the ingredients statement is shown immediately
under the name of the product or the milk is shown in a qualifying
statement contiguous to the product name.
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Goteborg A Swedish dry sausage made of coarsely chopped beef and
sometimes pork. Mildly seasoned with thyme. It has a somewhat
salty flavor and is heavily smoked, usually in long casings and air
dried.
Green Room A room in which freshly prepared sausages are held, to promote the
growth of lactic acid–forming bacteria before they are moved to a
drying room.
Ground Beef and Pork The product must be treated for possible live trichinae. Mixtures of
fresh ground pork and beef should not be distributed from official
establishments unless the pork is trichinae treated.
Hearts / Heart Meat Hearts and heart meat may not be labeled as “beef”, “pork”, etc. in
the ingredients statement. When used in a product, they must be
identified by species (e.g., “Beef Hearts”).
Heat and Eat Sausages Not the same as Brown and Serve Sausage. When the “heat and
eat” term is used, the product must comply with cooked sausage
regulations.
Holstein or Holsteiner Product is the same as Farm Style Sausage, except that it is stuffed
into wide casings and heavily smoked, usually in long casings, and
then is air-dried. No extenders are permitted.
Italian Style An acceptable term for products containing anise or fennel or Italian
type cheese, or at least three of the following (basil, garlic,
marjoram, olive oil or oregano).
Jowl The muscles and fatty tissues of the cheek that are cut away from
the jaw and left attached to the hog carcass.
Jerky Jerky products must have an MPR of 0.75:1 or less. The species or
kind must be in the name. These products may be cured or
uncured, dried, and may be smoked or un-smoked, and air or oven
dried.
Jumbo The term “Jumbo” may be used if the product is of a large size or
quantity. When used on frankfurters no more than 8 franks to the
pound may be present.
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Junior Meat Snacks This product must conform to the sausage standards going into the
jar before processing. Limited to 3 ½% extenders.
Kielbasa A sausage made with coarsely ground pork, sometimes with added
beef or mutton, that is cured, cooked, and usually smoked. By-
products are not permitted. Also available as a fresh sausage,
uncured with no more than 3% water.
Kippered Beef A cured dry product similar to beef jerky but not as dry (MPR 2.03:1)
Kolbase, Hungarian Finely ground cured beef and pork seasoned and stuffed into
Style casings and smoked. Classed as a cooked smoked sausage.
Labeling of Meat and Stick items such as beef jerky, pepperoni sticks and beef sticks
Poultry Stick Items have specific labeling requirements. Individual items sold in fully
labeled bulk containers are not required to be labeled. Individual
items sold in un-labeled bulk containers must be individually
labeled. Individual items sold in retail boxes or cartons are not
required to have individual labels.
Labeling of Modified Fresh sausages that contain non-meat or poultry “fat replacing
Substitute Versions of ingredients” must follow nutrition labeling regulations that include
Fresh Sausage specifying contents and conforming to applicable limits on
ingredients.
Lactobacillus A genus of bacteria that form lactic acid as they grow. Cultures of
these bacteria are added to certain meat and dairy foods to produce
a characteristic flavor and odor.
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Lola and Lolita A dry sausage product of Italian origin, consisting of mildly
seasoned pork and containing garlic. Lolita comes in 14 oz. Links,
while Lola comes in 2 ½ lb. links.
Longaniza and Puerto Longaniza is an acceptable name for Puerto Rican sausage made
Rican Longaniza from pork, which may contain beef but does not contain annatto.
Added fat is not permitted.
Loukanika An acceptable name for cooked fresh Greek sausage, usually made
with lamb and pork, and containing oranges, allspice, whole pepper
and salt.
Lyons Sausage A dry sausage made exclusively of pork with spices and garlic
which is stuffed into large casings, cured and air-dried.
Meat Meat is defined by USDA as the part of muscle of any cattle, sheep,
swine, goats, or equine animals that is skeletal or that is found in
the tongue, diaphragm, heart, or esophagus, with or without an
accompanying layer of fat. This also can include accompanying
portions of the bone, skin, sinew, nerve, and blood vessels that are
not separated from the muscle tissue during the dressing
procedure, but does not include the muscle found in the lips,
snouts, or ears [refer FSIS Regulations, 9 CFR 301.2(rr)].
Meat by-products Meat by-products include any part derived from cattle, sheep,
swine, goats, or equine animals, other than the parts defined above
as meat, that can be used as human food. These are also referred
to as “Variety Meats”. Examples of by-products are snouts, skins,
spleens, hearts, livers, and fat.
Meat Block The amount of meat and or meat byproducts used to make a
specific sausage batch.
Mettwurst, Cooked Mettwurst which is cooked must be labeled Cooked Mettwurst, and
may contain up to 10% water based on the finished product weight.
Metz Sausage Cured lean beef and pork and bacon are finely chopped, seasoned,
and stuffed into beef middles. It is air dried for 5 days, then given a
cool smoke. It is classified as a semi-dry sausage.
Mexican Style Acceptable name for products that contain at least four of the
following ingredients: jalapeno peppers, chili peppers, green chilies,
cumin, cayenne peppers, red or green peppers, chili powder,
jalapeno powder, Monterey Jack cheese, or cheddar cheese.
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Moisture Protein Ratio Used to describe the moisture level in a product. Non-refrigerated
(MPR) or shelf stable sausages, must have a MPR of 3.1:1 or less, and a
pH of 5.0 or less, unless commercially sterilized.
Mortadella Without Fat Product must meet the standard for Mortadella and the label
Cubes or Chunks qualified to indicate the absence of fat cubes or pork chunks, e.g.,
“Mortadella without fat cubes”.
Natural Smoked Color This statement on a label indicates on the product is smoked and
not artificially colored. Note that this label allows the use of artificial
smoke.
Negative Labeling Negative labeling is allowed if it is unclear from the product name
that the ingredient is not present. For example, the use of the term
“No Beef” on the label for Turkey Pastrami would further clarify that
the product does not contain beef.
Off-condition Spoiled.
Partially Defatted (Beef These are by-products produced from fatty trimmings containing
or Pork) Fatty Tissue less than 12% lean meat. These ingredients may be used in meat
products in which by-products are acceptable.
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Pepperoni A dry sausage prepared from Pork or Pork and Beef. Pepperoni
must be treated from destruction of possible live trichinae and have
a MPR of 1.6:1 or less. Antioxidants are permitted.
Pepperoni, with Poultry Poultry may be added to Pepperoni if properly labeled. If the meat
block contains 20% or less poultry, the product is labeled
“Pepperoni with Turkey Added”. When poultry is over 20% of the
meat and poultry block, it is labeled Pork and Turkey Pepperoni".
When poultry is over 50% of the meat and poultry block, it is labeled
Turkey and Pork Pepperoni”.
Pickled Products, Dry Products that are pickled or dry packed should be qualified with the
Packed name of the pickle as part of the product name (e.g., Knockwurst
Pickled”). The weight of the package shall be the weight of the
product less the weight of the pickle that will weep out of the
product.
Pimiento Sausage Pimientos are permitted when declared in the product name as
“Pimiento Sausage”.
Pinkelwurst A cooked product that is stuffed into a casing with a diameter from 1
½ to 2 inches and a length of about 10 to 12 inches. It is formulated
with beef, pork, fat, onions, oat groats, water, and sufficient spice to
satisfy seasoning requirements. The product is cooked to an
internal temperature of more than 1520F.
Polish Sausage A sausage that is cured, cooked, and usually smoked. Pork and
pork by-products shall comprise at least 50% of the meat and meat
by-products ingredients. Products with beef as the predominant
ingredient are called “beef and Pork Polish Sausage”. Green
peppers are permitted up to 4% in total formulation. A uncured
(fresh ) uncooked variety also with no more than 3% water also
exists.
Polynesian Style A sausage product that must contain fruit juices, a sweetening
Sausage agent, and soy sauce.
Pork and Bacon Up to 50% bacon is permitted in this type of sausage as long as
Sausage bacon is brought back to green weight before use, the product is
trichinae treated, and the product name is “Pork and Bacon
Sausage”. The standard for “Pork Sausage and/with Bacon” is
10% to 20% bacon, and for “Pork and Bacon Sausage” is more than
20% but not more than 50% bacon.
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Pork Sausage A product identified as pork sausage does not include the use of
pork cheeks. When such an item is offered as “Whole Hog”,
tongues, hearts, and cheeks may be used in the natural proportion
found in the hog carcass. “Fresh” shall be used in the name when
the product is not cured, cooked and/or smoked.
Pork Skins Pork Skins are not permitted in salami, bologna, frankfurters, vienna
sausage, and braunschweiger. When packaged in vinegar pickle,
they are not permitted to be artificially colored. When pork skin is
used to manufacture meat or poultry products, it must be specifically
listed in the ingredients statement (e.g., Pork Skins, Unskinned Pork
Jowls, Unskinned Pork Fat, etc.).
Potato Sausage or Ring A cooked or uncooked meat food product that: is at least 65% meat
and no by-products, water limited to 3% at formulation, No
extenders or binders permitted, and contains at least 18% potatoes.
Potentially Hazardous Potentially Hazardous Foods (PHF), according to the FDA Food
Foods (PHF) Code, refers to a food that requires temperature control because it
is in a form capable of supporting:
§ The rapid and progressive growth of infectious or toxigenic
microorganisms;
§ The growth and toxin production of Clostridium botulinum; or in
raw shell eggs, the growth of Salmonella Enteritidis.
Ready to Eat A product that has been cooked and has characteristics of a fully
cooked material. Will not receive further cooking by consumer.
Relative Humidity The amount of water vapor in the air expressed as a percentage of
the maximum amount of water the air could hold at a given
temperature.
Rework Fully or partially processed product, rerouted for reasons other than
unwholesomeness or adulteration.
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Shank The distal end of the fore and hind legs of a dressed carcass.
Shelf Stable Products that have been sufficiently treated to destroy all viable
forms of pathogenic organisms and nonpathogenic organisms
capable of reproducing in the product under normal non-refrigerated
conditions of storage and distribution.
Silent Cutter The commercial name for a machine that mixes and grinds sausage
ingredients. Ingredients are placed into a revolving tub that carries
the ingredients into rapidly rotating knife blades that chop and
emulsify the material.
Standard of Identity The minimum requirements (cut, ingredients, processing, etc.) for a
meat food product to be identified or labeled with an established or
acceptable name.
Swedish Style A cooked or uncooked meat food product that: is at least 45% meat
and no by-products, water limited to 3% at formulation, extenders
or binders up to 3.5% permitted except that 2% of isolated soy
protein shall be deemed to be equivalent of 3.5% of any of the other
binders or extenders, and contains at least 18% potatoes.
Poultry Sausage Sausage products made from poultry must be labeled to indicate
kind (e.g., “Chicken Sausage”, “Turkey Bologna”, etc.). Products
containing more than one kind of poultry or red meat must declare
the added ingredients in the product name (e.g., “Chicken Bologna,
Beef Added”, “Turkey Franks, Chicken Hearts Added”). The basic
sausage standards also apply to poultry, except for added water
and ice.
Romanian Brand An uncooked smoked sausage made with cured lean pork. Product
Sausage requires trichinae treatment.
Salami, Cooked The product “Salami” must be labeled to include the word “Cooked”
regardless of the type and size of its packaging, unless it is one of
the following:
- A salami with a MPR of no more than 1.9:1.
- Genoa Salami with a MPR of no more than 2.3:1
- Sicilian Salami with a MPR for no more than 2.3:1
- Labeled as Kosher Salami, Kosher Beef Salami, Beef Salami,
Beer Salami, or Salami for Beer.
Salami, Cotto A mildly flavored, cooked, cured sausage in a large casing, usually
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containing coarsely ground beef and pork. The product contains
whole or visible pieces of peppercorns. It is cooked in dry heat.
Salami, German Brand A dry sausage with an MPR of 1.9:1. It is made with beef and pork
Made in U.S.A. and seasoned with garlic. Less highly flavored but usually more
heavily smoked than Italian Salami. It is tied with loops of twine that
gives it a scalloped appearance.
Salami, Italian This dry salami is usually prepared in the San Francisco area and is
easily distinguished by it’s covering of a white mold. It consists of
about 80% finely chopped pork, to which a small amount of pork fat
may be added. Nonfat dry milk can compromise 3½ % of the
finished product. The remainder consists of chopped beef,
seasoning, salt, and curing agent. The product should have an
MPR of not in excess of 1.9:1 to ensure the fat content and dryness
properties associated with a “Dry salami”.
Salami, Sicilian Brand An acceptable name for an uncooked dry sausage. This is a type of
Made in U.S.A “Genoa Salami” except it is uncooked and contains no garlic.
Antioxidants are permitted. Trichinae treatment is required.
Salchichon A Spanish term meaning “Large Sausage”. This term may only be
used for large casing sausage products that are 3 inches in
diameter or more. Label must show true product name.
Salcina (Portuguese Sausage usually contains pork, green onions, parsley, vinegar, salt,
Brand – Made in U.S.A.) sugar, spices, and garlic.
Salpicao A smoked sausage. The label must show a true product name
(e.g., Smoked Sausage”). No more than 3% water can be added at
formulation.
Sarno A dry smoked sausage that is air-dried. The label must show a true
product name (e.g., “Smoked Sausage”). Coarsely chopped beef,
pork, and garlic are not permitted.
Sausage Made of fresh uncured meat, generally cuts of fresh pork and
Classifications – Fresh sometimes beef. (See this manual for more on this classification of
Sausage sausage)
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Uncooked Smoked
Sausage
Sausage Containing Sausages may contain cheese under the following conditions: if
Cheese there is a standard for that particular sausage, it must be met as
though it contained no cheese; The cheese must characterize the
product and appear as part of the product name (for example,
“Italian Sausage with Cheese”).
Sausage Containing Red meat sausages may contain raw and/or cooked poultry or
Poultry poultry meat. Poultry by-products are permitted when a sausage
standard permits by-products. Mechanically deboned poultry must
have kidneys and sex glands removed. Labeling standards must be
followed.
Sausage – Shelf Stable Dry sausages must have an MPR of 1.9:1 or less, unless an MPR is
cited under Moisture Protein Ratio. Non-refrigerated, semi-dry,
shelf stable sausage must have an MPR of 3.1:1 or less, and a pH
of 5.0 or less, unless commercially sterilized, or unless an MPR is
stated under Moisture Protein Ratio.
Alternately, non-refrigerated, semi-dry, shelf stable sausages are
those that:
- are fermented to a pH of 4.5 or lower (or pH may be as high as
4.6 if combined with product water activity no higher than 0.91),
- are in an intact form, or, if sliced, are vacuum packed,
- have internal brine concentration no less than 5%,
- are cured with nitrite or nitrate, and
- are smoked with wood.
Sausage, Raw Skeletal The term “raw skeletal muscle meat" includes beef cheek meat,
Muscle Meat Used in diaphragm meat, uncooked ham trimmings, and bacon or bacon
Emulsified Product ends and pieces. The bacon ingredient is limited to not more than
(Bologna, Franks, etc.) 10% of the meat, meat and meat by-products, or meat, meat by-
products and poultry products in a sausage formula. See FSIS
Regulation §318.180.
Sausage, Rework This term refers to a fully or partially processed product (excluding
uncooked trimmings) re-routed for reasons other than
unwholesomeness or adulteration and intended for inclusion in
cooked sausage, loaves, or similar products.
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Sausage, Smoked Smoked product will be identified as such unless the specific
product name conveys a smoked product or it is obvious from the
packaging.
Sausage Type Products Sausage type products that contain unexpected ingredients that
with Fruit and significantly alter the character of the product may be descriptively
Vegetables labeled with the characterizing ingredient (e.g., Cherry Pecan
Sausage, Wild Rice Sausage, etc.). The sausage portion must
meet the applicable standards based on the product weight prior to
adding the unexpected ingredient.
Sausage (Species) (Species) sausages must comply with the applicable standards
before being processed if the product name is to include the
species. For example cooked, cured sausages may be labeled
“cooked cured sausage” or “cooked cured sausage made with
(species)”.
Schickenwurst This product is made of two parts, one is an emulsion prepared from
pork and beef cuts, the other consists of chunks of ham measuring
from 2 to3 inches in size. The parts are mixed, stuffed into large
casings and smoked while being cooked. The final product appears
as a luncheon sausage with large pieces of red ham meat held
together by a light pink binder. The ham portion must comprise at
least 50% of the product, and the product has a distinctive smoked
flavor.
Serkelki, Serdelowa A cooked smoked sausage of Polish origin, made from pork. The
label must show a true product name (e.g., Smoked Sausage).
Smoke Although not required or customary, smoke can also appear in the
ingredients statements of domestically produced products which are
physically smoked. If included in the ingredients statement, smoke
should appear last.
Smoked Products The guidelines for approving labels for products prepared with
natural smoke and/or smoke flavoring are as follows:
- Products that have been exposed to smoke generated from
burning hardwoods may be labeled as “Smoked”, or with the
term “Naturally Smoked" to indicate that the traditional smoking
process was used.
- Products that have been exposed to natural liquid smoke flavor
that has been transformed into a true gaseous state by
application of heat, or transformed into vapor by mechanical
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means, may be labeled “Smoked”.
- Products that have been exposed to natural liquid smoke flavor
via spraying, dipping, liquid flooding, or similar processes prior
to or during heat processing, may be labeled “Smoked”.
- Products that have been exposed to natural or artificial smoke
flavor via direct application to the product surface or via injection
must be labeled to identify the smoke flavor as part of the
product name (e.g., “Pork Sausage, Natural Smoke Flavor
Added”.)
Smoked Sausage, An uncured or cooked smoked sausage with natural spices and
Country Style sugar. It is made with beef and pork and requires trichinae
treatment.
Smoky Snax A smoked sausage. The label must show a true product name
(“Smoked Sausage” or “Dry Sausage”).
Southern Hots A cooked smoked sausage made in the South. Southern Hots is a
coined name that must be accompanied by a true product name.
Soy Protein Products Whenever soy products are used in a meat or poultry product, they
must be called by their common or usual name (e.g., soy flour, soy
protein isolate, etc.). If these products are textured, then “textured”
should also be included in the name.
Spices The term spices refers to genuine natural spices, whole or ground.
Spices may be listed as “Flavorings”.
Summer Sausage A semi dry or cooked sausage that can contain meat by-products
and extenders.
Teawurst or Teewurst A cooked or uncooked product processed without curing and cold
smoked 2 to 5 days. It is ground or coarsely chopped as is
characterized by a soft spreadable texture. Typical meat
ingredients include pork, beef, pork bellies and bacon.
Texas Hots A coined name for a sausage made in Texas. The label must show
a true product name.
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Summer Sausage”, “Thuringer Cervelat”, and “Summer
Sausage - Thuringer Cervelat
Trichinae Treatment All sausage and meet food products containing pork that are neither
cooked or understood by the public as needing to be cooked prior to
serving must be treated by one of the prescribed methods. See
FSIS Regulations §318.10.
Turkey Braunschweiger The product name must be shown on the label as “Turkey Liver
Sausage”. No by-products other than liver are permitted in the
product.
Ukrainian Sausage A dry sausage made from lean pork and/or veal chunks, containing
large amounts of garlic that dominates the flavor. It is cooked and
smoked at high temperatures (around 180 – 1850F) for 4-5 hours
then air-dried. The water activity or the finished product shall not
exceed 0.92 or an MPR of 2.0:1 or less.
Uncured (Labeling Products in which nitrites or nitrates are required or expected, may
Requirements Labeled be prepared without such cures when the product name is
As) immediately preceded by the term “Uncured” as part of the product
name in the same size and style of lettering. The "uncured” product
must comply with the standard performance characteristics for the
cured product. See FSIS Regulation §319.2.
Vacuum Mixer A mechanical device used to mix sausage emulsions under vacuum
in order to reduce the occurrence of air pockets in the finished
product.
Variety Meats in Franks Cooked sausages with variety meats must contain not less than
15% red skeletal meat based in the total meat block.
Whole Hog Sausage Must contain all primal parts of a hog, such as hams and loins.
Hearts and tongues, in natural proportions, are permitted
ingredients when declared in the ingredients statement. Other meat
by-products are not permitted. See FSIS Regulations §319.144.
Wholesomeness Not adulterated. All meat and meat by-products used in sausage
formulations must be clean, wholesome and properly labeled. The
manufacturing facility must inspect all incoming meat to ensure that
is not contaminated. Even previously inspected meat must be re-
inspected to ensure that it has not become contaminated during
transit.
Page 58
Appendices
This manual contains the following appendices:
Page 59
Page 60
Appendix: A
Process Flow Diagram
Receiving Receiving
Packaging Non-Meat Ingredients
Materials
Storage
Non-Meat Ingredients
Receiving Meat
Assemble / Pre-Weigh
Non-Meat Ingredients Storage Meat (Cold)
Storage Rework
Packaging Sausage Stuffer
Materials
Packaging / Labeling
Page 61
Process Flow Diagram
Receiving Receiving
Casings/ Raw Meat Receiving Receiving
Packaging Restricted Non- Unrestricted
Materials Meat Food Non-Meat Food
Ingredients Ingredients
Storage
(Cold – Frozen/Refrigerated)
Raw Meat Storage Storing
Restricted Non- Unrestricted
Meat Food Non-Meat Food
Ingredients Ingredients
Tempering
Frozen Meat
Weighing Weighing
Restricted Non- Unrestricted
Preparation of Meat Food Non-Meat Food
Raw Meat Ingredients Ingredients
Combine Ingredients /
Processing (List All)
Rework Stuffing
Cooking/Smoking
Chilling
Storage
Casings/ Portioning (if done)
Packaging
Materials
Packaging / Labeling
Page 62
Process Flow Diagram
Receiving Receiving
Packaging Raw Meat Receiving Receiving
Materials Restricted Non- Unrestricted
Meat Food Non-Meat Food
Ingredients Ingredients
Storage
(Cold – Frozen/Refrigerated)
Raw Meat
Storage Storing
Restricted Non- Unrestricted
Meat Food Non-Meat Food
Ingredients Ingredients
Tempering
Frozen Meat
Weighing Weighing
Restricted Non- Unrestricted
Weighing Meat Food Non-Meat Food
Raw Meat Ingredients Ingredients
Combine Ingredients /
Processing (List All)
Preparing
Starter
Cultures /
Casings
Rework Fermenting
Storage
Starter
Cultures /
Drying Casings
Receiving
Slicing / Peeling Starter
Cultures /
Casings
Storage
Packaging Packaging / Labeling
Materials
Packaging / Labeling
Page 63
Process Flow Diagram
Receiving Receiving
Packaging Raw Meat / Poultry Receiving Restricted
Receiving
Materials Non-Meat Non-
Unrestricted Non-
Poultry Food
Meat Non-Poultry
Ingredients
Food Ingredients
Storage
(Cold – Frozen/Refrigerated)
Raw Meat / Poultry
Storage Restricted Storing
Non-Meat Non- Unrestricted Non-
Poultry Food Meat Non-Poultry
Ingredients Food Ingredients
Tempering
Frozen Meat / Poultry
Combine Ingredients /
Processing (List All)
Drying
Cooling / Equilibration
Storage
Packaging
Materials
Packaging / Labeling
Page 64
Appendix: B Applicable FSIS Regulations
Selected text of the FSIS Regulations that pertain to this training program;
*** marks missing material; please see
http://www.access.gpo.gov/nara/cfr/cfr-retrieve.html#page1 for complete text.
(a) All ingredients and other articles used in the preparation of any
product shall be clean, sound, healthful, wholesome, and otherwise such as
will not result in the product being adulterated. Official establishments
shall furnish inspectors accurate information on all procedures involved in
product preparation including product composition and any changes in such
procedures essential for inspectional control of the product.
(b)(1) The only animal casings that may be used as containers of product
are those from cattle, sheep, swine, or goats.
(2) Casings for products shall be carefully inspected by Program
employees. Only those casings which have been carefully washed and thoroughly
flushed with clean water immediately before stuffing and are suitable for
containers, are clean, and are passed on such inspection shall be used,
except that preflushed animal casings packed in salt or salt and glycerine
solution or other approved medium may be used without additional flushing
provided they are found to be clean and otherwise acceptable and are
thoroughly rinsed before use.
(3) Hog and sheep casings intended for use as containers of product may
be treated by soaking in or applying thereto sound, fresh pineapple juice or
papain or bromelin or pancreatic extract to permit the enzymes contained in
these substances to act on the casings to make them less resistant. The
casings shall be handled in a clean and sanitary manner throughout and the
treatment shall be followed by washing and flushing the casings with water
sufficiently to effectively remove the substance used and terminate the
enzymatic action.
***
Page 65
cured to destroy any possible live trichinae, as prescribed in this section
at the official establishment where such products are prepared: Bologna,
frankfurter, vienna, and other cooked sausage; smoked sausage; knoblauch
sausage; mortadella; all forms of summer or dried sausage, including
mettwurst; flavored pork sausages such as those containing wine or similar
flavoring materials; cured pork sausage; sausage containing cured and/or
smoked pork; cooked loaves; roasted, baked, boiled, or cooked hams, pork
shoulders, or pork shoulder picnics; Italian-style hams; Westphalia-style
hams; smoked boneless pork shoulder butts; cured meat rolls; capocollo
(capicola, capacola); coppa; fresh or cured boneless pork shoulder butts,
hams, loins, shoulders, shoulder picnics, and similar pork cuts, in casings
or other containers in which ready-to-eat delicatessen articles are
customarily enclosed (excepting Scotch-style hams); breaded pork products;
cured boneless pork loins; boneless back bacon; bacon used for wrapping
around patties, steaks and similar products; and smoked pork cuts such as
hams, shoulders, loins, and pork shoulder picnics (excepting smoked hams, and
smoked pork shoulder picnics which are specially prepared for distribution in
tropical climates or smoked hams delivered to the Armed Services); ground
meat mixtures containing pork and beef, veal, lamb, mutton, or goat meat and
other product consisting of mixtures of pork and other ingredients, which the
Administrator determines at the time the labeling for the product is
submitted for approval in accordance with part 317 of the regulations in this
subchapter or upon subsequent reevaluation of the product, would be prepared
in such a manner that the product might be eaten rare or without thorough
cooking because of the appearance of the finished product or otherwise. Cured
boneless pork loins shall be subjected to prescribed treatment for
destruction of trichinae prior to being shipped from the establishment where
cured.
(c) The treatment shall consist of heating, refrigerating, or curing, as
follows:
(1) Heating. (i) All parts of the pork muscle tissue shall be heated
according to one of the time and temperature combinations in the following
table:
-------------------------------------------------------------------
Minimum internal temperature
--------------------------------------------------
Degrees Minimum time
Degrees fahrenheit centigrade
-------------------------------------------------------------------
120............................. 49.0 21 hours.
122............................. 50.0 9.5 hours.
124............................. 51.1 4.5 hours.
126............................. 52.2 2 hours.
128............................. 53.4 1 hour.
130............................. 54.5 30 minutes.
132............................. 55.6 15 minutes.
134............................. 56.7 6 minutes.
136............................. 57.8 3 minutes.
138............................. 58.9 2 minutes.
140............................. 60.0 1 minute.
142............................. 61.1 1 minute.
144............................. 62.2 Instant.
-------------------------------------------------------------------
Page 66
(5.1 cm) and refrigeration of the product does not begin within 5 minutes of
attaining 138 deg. F (58.9 deg. C).
(v) The establishment shall use procedures which insure the proper
heating of all parts of the product. It is important that each piece of
sausage, each ham, and other product treated by heating in water be kept
entirely submerged throughout the heating period; and that the largest pieces
in a lot, the innermost links of bunched sausage or other massed articles,
and pieces placed in the coolest part of a heating cabinet or compartment or
vat be included in the temperature tests.
(v) During the period of refrigeration the product shall be kept separate
from other products and in the custody of the Program in rooms or
Page 67
compartments equipped and made secure with an official Program lock or seal.
The rooms or compartments containing product undergoing freezing shall be
equipped with accurate thermometers placed at or above the highest level at
which the product undergoing treatment is stored and away from refrigerating
coils. After completion of the prescribed freezing of pork to be used in the
preparation of product covered by paragraph (b) of this section the pork
shall be kept under close supervision of an inspector until it is prepared in
finished form as one of the products enumerated in paragraph (b) of this
section or until it is transferred under Program control to another official
establishment for preparation in such finished form.
(vi) Pork which has been refrigerated as specified in this subparagraph
may be transferred in sealed railroad cars, sealed motortrucks, sealed
trailers, or sealed closed containers to another official establishment at
the same or another location, for use in the preparation of product covered
by paragraph (b) of this section. Such vehicles and containers shall be
sealed and transported between official establishments in accordance with
Sec. 325.7 of this subchapter.
Method No. 1. The meat shall be ground or chopped into pieces not exceeding three-fourths of
an inch in diameter. A dry-curing mixture containing not less than 3 1/3 pounds of salt to each
hundredweight of the unstuffed sausage shall be thoroughly mixed with the ground or chopped meat.
After being stuffed, sausage having a diameter not exceeding 3 1/2 inches, measured at the time
of stuffing, shall be held in a drying room not less than 20 days at a temperature not lower than
45 deg.F., except that in sausage of the variety known as pepperoni, if in casings not exceeding
1 3/8 inches in diameter measured at the time of stuffing, the period of drying may be reduced
to 15 days. In no case, however, shall the sausage be released from the drying room in less than
25 days from the time the curing materials are added, except that sausage of the variety known as
pepperoni, if in casings not exceeding the size specified, may be released at the expiration of
20 days from the time the curing materials are added. Sausage in casings exceeding 3 ½ inches,
but not exceeding 4 inches, in diameter at the time of stuffing, shall be held in a drying room
not less than 35 days at a temperature not lower than 45 deg.F., and in no case shall the
sausage be released from the drying room in less than 40 days from the time the curing materials
are added to the meat.
Method No. 2. The meat shall be ground or chopped into pieces not exceeding three-fourths of
an inch in diameter. A dry-curing mixture containing not less than 3 1/3 pounds of salt to each
hundredweight of the unstuffed sausage shall be thoroughly mixed with the ground or chopped meat.
After being stuffed, sausage having a diameter not exceeding 3 ½ inches, measured at the time of
stuffing, shall be smoked not less than 40 hours at a temperature not lower than 80 deg.F., and
finally held in a drying room not less than 10 days at a
temperature not lower than 45 deg.F. In no case, however, shall the sausage be released from the
drying room in less than 18 days from the time the curing materials are added to the meat.
Sausage exceeding 3 ½ inches, but not exceeding 4 inches, in diameter at the time of stuffing,
shall be held in a drying room, following smoking as above indicated, not less than 25 days at a
temperature not lower than 45 deg.F., but in no case shall the sausage be released from the
drying room in less than 33 days from the time the curing materials are added to the meat.
Method No. 3. The meat shall be ground or chopped into pieces not exceeding three-fourths of
an inch in diameter. A dry-curing mixture containing not less than 3 1/3 pounds of salt to each
hundredweight of the unstuffed sausage shall be thoroughly mixed with the ground or chopped meat.
After admixture with the salt and other curing materials and before stuffing, the ground or
chopped meat shall be held at a temperature not lower than 34 deg.F. for not less than 36 hours.
After being stuffed, the sausage shall be held at a temperature not lower than 34 deg.F. for an
additional period of time sufficient to make a total of not less than 144 hours from the time the
curing materials are added to the meat, or the sausage shall be held for the time specified in a
pickle-curing medium of not less than 50 deg. strength (salometer reading) at a temperature not
lower than 44 deg.F. Finally, sausage having a diameter not exceeding 3 ½ inches, measured at
the time of stuffing, shall be smoked for not less than 12 hours. The temperature of the
smokehouse during this period at no time shall be lower than 90 deg.F.; and for 4 consecutive
hours of this period the smokehouse shall be maintained at a temperature not lower than 128
deg.F. Sausage exceeding 3 ½ inches, but not exceeding 4 inches, in diameter at the time of
Page 68
stuffing shall be smoked, following the prescribed curing, for not less than 15 hours. The
temperature of the smokehouse during the 15-hour period shall at no time be lower than 90 deg.F.,
and for 7 consecutive hours of this period the smokehouse shall be maintained at a temperature
not lower than 128 deg.F. In regulating the temperature of the smokehouse for the treatment of
sausage under this method, the temperature of 128 deg.F. shall be attained gradually during a
period of not less than 4 hours.
Method No. 4. The meat shall be ground or chopped into pieces not exceeding one-fourth of an
inch in diameter. A dry-curing mixture containing not less than 2 ½ pounds of salt to each
hundredweight of the unstuffed sausage shall be thoroughly mixed with the ground or chopped meat.
After admixture with the salt and other curing materials and before stuffing, the ground or
chopped sausage shall be held as a compact mass, not more than 6 inches in depth, at a
temperature not lower than 36 deg.F. for not less than 10 days. At the termination of the
holding period, the sausage shall be stuffed in casings or cloth bags not exceeding 3 1/3 inches
in diameter, measured at the time of stuffing. After being stuffed, the sausage shall be held in
a drying room at a temperature not lower than 45 deg.F. for the remainder of a 35-day period,
measured from the time the curing materials are added to the meat. At any time after stuffing, if
the establishment operator deems it desirable, the product may be heated in a water bath for a
period not to exceed 3 hours at a temperature not lower than 85 deg.F., or subjected to smoking
at a temperature not lower than 80 deg.F., or the product may be both heated and smoked as
specified. The time consumed in heating and smoking, however, shall be in addition to the 35-day
holding period specified.
Method No. 5. The meat shall be ground or chopped into pieces not exceeding three-fourths of
an inch in diameter. A dry-curing mixture containing not less than 3 1/3 pounds of salt to each
hundredweight of the unstuffed sausage shall be thoroughly mixed with the ground or chopped meat.
After being stuffed, the sausage shall be held for not less than 65 days at a temperature not
lower than 45 deg.F. The coverings for sausage prepared according to this method may be coated
at any stage of the preparation before or during the holding period with
paraffin or other substance approved by the Administrator.
Method No. 6. (A) Basic requirements. The meat shall be ground or chopped into pieces not
exceeding three-fourths of an inch in diameter. A dry-curing mixture containing not less than
3.33 pounds of salt to each hundredweight of the unstuffed sausage, excluding the weight of dry
ingredients, shall be thoroughly mixed with the ground or chopped meat. After the curing mixture
has been added, the sausage shall be held for two time periods, a holding period and a drying
period. The holding period will be for a minimum of 48 hours at a room temperature not lower than
35 deg.F. This holding period requirement may be fulfilled totally or in part before the drying
period and then the remainder, if any, after the drying period or as an extension of the drying
period. During the drying period, the sausage shall be held in a drying room at a temperature not
lower than 50 (10.0 deg.F. 10.0 deg.C) for a period of time determined by Tables 3A, 3B, and 4.
The length of the drying period, established in (c)(3)(i)(A), may be modified as provided in
paragraphs (c)(3)(i)(B) and (c)(3)(i)(C) of this section.
(B) Reduction in Drying Room Time. During the holding period, the sausage may be smoked or
fermented. If the temperature is increased to 70 deg.F. (21.1 deg.C) or higher, while the sausage
is being held after adding curing materials but before the drying period, the subsequent drying
room times prescribed for this method may be reduced according to the schedule in Table 3B. No
interpolation of values is permissible.
Page 69
Holding Times and Temperatures Prior to Drying \1\
-------------------------------------------------------------------------------------------------
--
Minimum temperature \2\
-------------------------------------------------------------------------------------------------
--
Minimum Time 70F 75F 80F 85F 90F 95F 100F 105F 110F 120F
-------------------------------------------------------------------------------------------------
--
21.1C 23.9C 26.7C 29.5C 32.2C 35.0C 37.9C 40.6C 43.3C 48.9C
-------------------------------------------------------------------------------------------------
--
24 hour 4 5 8 10 15 23 37 57 90 \3\100
48 hours 9 12 18 25 35 49 88 \3\100 \3\100 100
72 hours 14 19 28 39 55 74 \3\100 100 100 100
96 hours 19 26 38 53 75 98 100 100 100 100
120 hours 24 33 48 67 95 \3\100 100 100 100 100
-------------------------------------------------------------------------------------------------
--
\1\ In computing the days to be deducted, the number with any fraction shall be rounded to the
next lower whole number and shall be deducted from the required total drying time. Example:
Sausage stuffed in 3" diameter casing requires 20 days in the drying room (from Drying Room
Times, Table 3A). If allowed to ferment, after addition of curing materials, at 80 F. for 48
hours, the 20 day drying time may be reduced 18% (from Table 3B). Eighteen percent of 20 day
equals 3.6 days. Twenty days minus 3 days equals 17 days. The total drying time required in the
drying room, therefore, will be 17 days.
\2\ Either room temperature or internal product temperature shall be used for sausages that will
be subsequently dried to a moisture-protein ratio of 2.3:1 or less. Internal product temperature
shall be used for all other sausages.
\3\ Trichinae will be destroyed during fermentation or smoking at the temperature and length of
time indicated. Therefore, no drying room period is required for products so treated.
(C) Reduced Salt Content--Drying Room Times. Salt content of less than 3.33 pounds for each
hundredweight of sausage formulation, excluding dry ingredients, (such as salts, sugars, and
spices), may be permitted provided the drying time is increased according to the schedule
contained in Table 4.
Page 70
Drying Room Times), or 9.2 days. The 9.2 is rounded up to 10 days and is added to the 23 days to
equal 33 days. The total drying time required in the drying room, therefore, will be 33 days.
Treatment Schedule for Sausages 105 Millimeters (4\1/8\ Inches) or Less in Diameter
------------------------------------------------------------------------
Minimum chamber temperature
------------------------------------------------- Minimum time (hours)
( deg.F) ( deg.C)
------------------------------------------------------------------------
50..................... 10 12
90..................... 32.2 1
100.................... 37.8 1
110.................... 43.3 1
120.................... 48.9 1
125.................... 51.7 7
------------------------------------------------------------------------
Following the preceding treatment, the establishment shall dry the sausages at a temperature not
lower than 50 deg.F (10 deg.C) for not less than 7 days.
(C) Heating and Drying Treatment, Small Sausages. Alternatively, the establishment may
subject sausages in casings not exceeding 55 mm in diameter, at the time of stuffing, to all of
the following minimum chamber temperatures and time periods.
Following the preceding heat treatment, the establishment shall dry the sausages at a temperature
not lower than 50 deg.F (10 deg.C) for not less than 4 days.
***
(d) General instructions: When necessary to comply with the requirements
of this section, the smokehouses, drying rooms, and other compartments used
in the treatment of pork to destroy possible live trichinae shall be suitably
equipped, by the operator of the official establishment, with accurate
automatic recording thermometers. Circuit supervisors are authorized to
approve for use in sausage smokehouses, drying rooms, and other compartments,
such automatic recording thermometers as are found to give satisfactory
service and to disapprove and require discontinuance of use, for purposes of
the regulations in this subchapter, any thermometers (including any automatic
recording thermometers) of the establishment that are found to be inaccurate
or unreliable.
***
Any product, such as frankfurters and corned beef, for which there is a
standard in this part and to which nitrate or nitrite is permitted or
Page 71
required to be added, may be prepared without nitrate or nitrite and labeled
with such standard name when immediately preceded with the term ``Uncured''
in the same size and style of lettering as the rest of such standard name:
Provided, That the product is found by the Administrator to be similar in
size, flavor, consistency, and general appearance to such product as commonly
prepared with nitrate and nitrite: And provided further, That labeling for
such product complies with the provisions of Sec. 317.17(c) of this
subchapter.
***
``Fresh Pork Sausage'' is sausage prepared with fresh pork or frozen pork
or both, but not including pork byproducts, and may contain Mechanically
Separated (Species) in accordance with Sec. 319.6, and may be seasoned with
condimental substances as permitted under part 318 of this subchapter. The
finished product shall not contain more than 50 percent fat. To facilitate
chopping or mixing, water or ice may be used in an amount not to exceed 3
percent of the total ingredients used.
Page 72
chopping or mixing, water or ice may be used in an amount not to exceed 3
percent of the total ingredients used. Binders or extenders may be added as
provided in Sec. 318.7(c)(4) of this subchapter.
``Whole Hog Sausage'' is sausage prepared with fresh and/or frozen meat
from swine in such proportions as are normal to a single animal, and may
include any Mechanically Separated (Species) produced from the animal and
used in accordance with Sec. 319.6, and may be seasoned with condimental
substances as permitted under part 318 of this subchapter. The finished
product shall not contain more than 50 percent fat. To facilitate chopping or
mixing, water or ice may be used in an amount not to exceed 3 percent of the
total ingredients used.
Page 73
(c) If Italian sausage products are cooked or smoked, determination of
compliance with the provisions of paragraphs (a) and (b) of this section
shall be based on the uncooked or unsmoked product. The product before
cooking or smoking shall contain no more than 3 percent water as specified in
paragraph (b)(2) of this section. Product which is cooked shall be labeled
with the word ``cooked'' in the product name, such as ``Cooked Italian
Sausage'' or ``Cooked Cured Italian Sausage.'' Product which is smoked shall
be labeled with the word ``smoked'' in the product name, such as ``Smoked
Italian Sausage'' or ``Smoked Cured Italian Sausage.'' The words ``cooked''
and ``smoked'' shall be displayed on the product label in the same size and
style of lettering as other words in
the product name.
G--Cooked Sausage
Page 74
partially defatted beef fatty tissue, or a combination of both, may be used
in an amount not exceeding 15 percent of the meat and meat byproducts or
meat, meat byproducts, and poultry products ingredients. The finished
products shall not contain more than 30 percent fat. Water or ice, or both,
may be used to facilitate chopping or mixing to dissolve the curing and
seasoning ingredients, the sausage shall contain no more than 40 percent of a
combination of fat and added water. These sausage products may contain only
phosphates approved under part 318 of this chapter. These sausage products
may contain poultry products and/or Mechanically Separated (Kind of Poultry)
used in accordance with Sec. 381.174, individually or in combination, not in
excess of 15 percent of the total ingredients, excluding water, in the
sausage, and may contain Mechanically Separated (Species) used in accordance
with Sec. 319.6. Such poultry products shall not contain kidneys or sex
glands. The amount of poultry skin present in the sausage must not exceed the
natural proportion of skin present on the whole carcass of the kind of
poultry used in the sausage, as specified in Sec. 381.117(d) of this chapter.
The poultry products used in the sausage shall be designated in the
ingredient statement on the label of such sausage in accordance with the
provisions of Sec. 381.118 of this chapter. Meat byproducts used in the
sausage shall be designated individually in the ingredient statement on the
label for such sausage in accordance with Sec. 317.2 of this chapter.
(c) A cooked sausage as defined in paragraph (a) of this section shall be
labeled by its generic name, e.g., frankfurter, frank, furter, hotdog,
wiener, vienna, bologna, garlic bologna, or knockwurst. When such sausage
products are prepared with meat from a single species of cattle, sheep,
swine, or goats they shall be labeled with the term designating the
particular species in conjunction with the generic name, e.g., ``Beef
Frankfurter,'' and when such sausage products are prepared in part with
Mechanically Separated (Species) in accordance with Sec. 319.6, they shall be
labeled in accordance with Sec. 317.2(j)(13) of this subchapter.
(d) A cooked sausage as defined in paragraph (b) of this section shall be
labeled by its generic name, e.g., frankfurter, frank, furter, hotdog,
wiener, vienna, bologna, garlic bologna, or knockwurst, in conjunction with
the phrase ``with byproducts'' or ``with variety meats'' with such
supplemental phrase shown in a prominent manner directly contiguous to the
generic name and in the same color on an identical background.
(e) One or more of the binders and extenders as provided in Sec.
18.7(c)(4) of this subchapter may be used in cooked sausage otherwise
complying with paragraph (a) or (b) of this section. When any such substance
is added to these products, the substance shall be designated in the
ingredients statement by its common or usual name in order of predominance.
(f) Cooked sausages shall not be labeled with terms such as ``All Meat''
or ``All (Species),'' or otherwise to indicate they do not contain nonmeat
ingredients or are prepared only from meat.
(g) For the purposes of this section: Poultry meat means deboned chicken
meat or turkey meat, or both, without skin or added fat; poultry products
mean chicken or turkey, or chicken meat or turkey meat as defined in Sec.
381.118 of this chapter, or poultry byproducts as defined in Sec. 381.1 of
this chapter; and meat byproducts (or variety meats), mean pork stomachs or
snouts; beef, veal, lamb, or goat tripe; beef, veal, lamb, goat, or pork
hearts, tongues, fat, lips, weasands, and spleens; and partially defatted
pork fatty tissue, or partially defatted beef fatty tissue.
Page 75
use as provided in Sec. 318.7 are intended to be exclusive of the cheese
constituent. When any such substance is added to these products, the
substance shall be designated in the ingredients statement by its common or
usual name in order of predominance. These products shall contain no more
than 40 percent of a combination of fat and added water, and no more than 30
percent fat and shall comply with the other provisions for cooked sausages
that are in this subchapter.
``Meat Loaf'' is a cooked meat food product in loaf form made from
comminuted meat. Mechanically Separated (Species) may be used in accordance
with Sec. 319.6. To facilitate chopping or mixing, water or ice may be used
in an amount not to exceed 3 percent of the total ingredients used.
***
Page 76
Appendix: C FSIS Listeria Guidelines for Industry, May, 1999
The Food Safety and Inspection Service (FSIS) has published a Federal Register notice
to ensure that the owners and operators of federally inspected establishments are
aware of the Agency’s views about the application of its hazard analysis and critical
control point (HACCP) system regulations to contamination with Listeria.
monocytogenes, and to provide the public with an opportunity to comment on the
Agency’s views.
FSIS believes that the findings from testing a range of ready-to-eat products and
information from investigations of outbreaks of listeriosis constitute changes that could
affect an establishment’s hazard analysis and could alter the HACCP plan for affected
products. Therefore, under 9CFR417.4, establishments must reassess their HACCP
plans for ready-to-eat meat and poultry products. If reassessment results in a
determination that L. monocytogenes contamination is a food safety hazard reasonably
likely to occur in the production process, then it is a type of microbiological
contamination that must be addressed in a HACCP plan.
The Agency is in the process of revising FSIS Directive 10,240.2, Microbial Sampling of
Ready-to-Eat Products Produced By Establishments Operating Under A HACCP
System. The revision will address when inspection personnel should not collect product
samples for testing by FSIS if establishments are testing. The Agency is considering a
policy similar to that contained in FSIS Directive 10,010.1, Microbiological Testing
Program For Escherichia coli O157: H7 in Raw Ground Beef. Until FSIS Directive
10,240.2 is revised and issued, inspection personnel will continue to collect product
samples regardless of any testing being done by the establishment.
This document has been assembled using currently available scientific and technical
information from within the Agency and other parts of the government, from meat and
poultry processing establishments that have shared their successful approaches, and
from trade associations that have also shared their collective best thinking on how to
handle this difficult problem.
(the page before this should be 76, there is no page 1)
Page 2
BACKGROUND
In recent months there have been several recalls of RTE meat and poultry products
because of adulteration with L. monocytogenes. Foodborne illnesses and deaths have
been linked to some recalled products. It has generally been concluded that the
adulteration occurred through cross-contamination from environmental sources
following cooking. Industry for the most part, has identified this as an SSOP failure.
§ What are the levels of L. monocytogenes on source materials for your products? Do
levels fluctuate significantly depending on suppliers? Do levels fluctuate significantly
because of your practices regarding the use of rework product in various products?
Page 3
Cow / Bull 11.3% 43 MPN / cm2 0.3 MPN / cm2
carcasses
Market Hog 7.4% 46 MPN / cm2 0.3 MPN / cm2
carcasses
Broiler Chicken 15.0% 51 MPN / cm2 0.025 MPN / cm2
carcasses
Turkey carcasses 5.9% 0.30 MPN / cm2 0.02 MPN / cm2
Raw ground beef 11.7% >110 MPN / g 2.9 MPN / gram
Raw ground 41.1% 430 MPN / g 1.03 MPN / gram
chicken
Raw ground 30.5% 93 MPN / g 0.75 MPN / gram
turkey
a
Calculated from positive samples only.
§ What do your validation results tell you about the efficacy of kill steps used in your
processes? What in-plant experience do you have which confirms the efficacy of the
kill step you use on products produced from all types of source materials?
Challenge studies, scientific literature, computer modeling programs, and expert advice
from processing authorities can be used to validate a HACCP plan. However, the
effectiveness of the kill step under actual in-plant conditions would be evaluated through
the HACCP plan verification.
§ Do you produce meat and poultry products that will support the growth of L.
monocytogenes? What is the basis of your view? What are the implications for
storage temperatures and shelf-life?
Page 4
unopened hermetically sealed container, that is commercially processed to
achieve and maintain commercial sterility under conditions of non-refrigerated
storage and distribution; (4) laboratory evidence demonstrates that the rapid and
progressive growth of infectious or toxigenic microorganisms or the growth of C.
botulinum can not occur, and that may contain a preservative, other barrier to the
growth of microorganisms, or a combination of barriers that inhibit the growth of
microorganisms; or (5) the product does not support the growth of
microorganisms…"
§ What does finished product testing reveal about the status of your products with
respect to microbial contamination?
FSIS believes that findings of L. monocytogenes in finished product are
significant evidence that L. monocytogenes contamination may be a food safety
hazard reasonably likely to occur in the production process for that product.
Since 1989, FSIS has conducted finished product testing for L. monocytogenes
in several RTE meat and poultry product categories. The results found are as
follows:
Product Listeria
monocytogenes
Tested Positive Percent Positive
Jerky 575 4 0.7
Large Diameter 3099 51 1.6
Sausages
Cooked Uncured 6055 148 2.4
Poultry
Roast/Corned/Cooked 4900 150 3.1
Beef
Salads and Spreads 3619 124 3.4
Small Diameter 4980 219 4.4
Sausages
Sliced Ham/Luncheon 1360 78 5.7
Meats
SAMPLING PROGRAMS
The Agency envisions two types of sampling programs that establishments may use:
environmental and end product. Environmental sampling includes non-product contact
Page 5
surfaces, such as floors and drains, and product contact surfaces, such as conveyors,
belts, slicers, and peelers. End product testing covers RTE product. Examples of testing
programs in use in industry are provided in Attachment 1.
Establishments with limited resources should establish end product sampling as their
top priority, followed by product contact surface/non-product contact surface testing. A
comprehensive flowchart outlining environmental and end product testing is provided in
Attachment 2.
Methods
Environmental samples, including swabs and sponges, should be placed in a
neutralizing medium immediately after collection, in order to neutralize any residual
disinfectants that may be picked up from equipment or other environmental sampling
sites. Samples should be stored and shipped to laboratories using standardized
procedures. A reputable laboratory should analyze samples. The establishment is
responsible for determining the competency of the laboratory used. The laboratory
conducting the sample analyses should have properly trained personnel, suitable
facilities and equipment, a written quality assurance program that is available to all
personnel, and reporting and record keeping capabilities. Presently there is no AOAC-
approved method for analyzing environmental samples for Listeria. Laboratories can
use published methods after validation. Laboratories can also use FSIS’ L.
monocytogenes method published in the Microbiology Laboratory Guidebook, 3rd
edition (Chapter 8, Revision #1, 1/12/99).
An establishment may choose to perform its own indicator organism testing using a
screening test. Such tests are available but should be validated as part of the HACCP
plan.
Record Keeping
The results of environmental sampling are not available until after products are
produced. Therefore, adequate and accurate records are essential because the
Page 6
environmental sampling program is of retrospective value only. For example,
identification of the site sampled (drain #1 in peeling room) and the visible condition of
the site (clean, smooth surface) is necessary to effectively utilize the sampling results.
1. Once the product contact surface is found to be positive for the number of samples
indicated in the HACCP plan for Listeria spp., the next lot of product produced from
the line should be sampled and tested for L. monocytogenes.
2. Minimum production time prior to sampling should be determined by the plant and
followed. The time may depend on individual line configuration, clean up, and
sanitizing procedures. The testing plan should include variations in the time of
sampling to detect the increase in Listeria that could occur during the production
shift.
3. After product sampling, the line may need to be cleaned and/or operational
procedures reviewed, before production of the next lot.
4. The product lot sampled may be held, pending laboratory results.
5. If a sampled lot is found to be positive for L. monocytogenes, and is already in
commerce, it will be subject to recall.
6. Product sampling may be intensified, such as testing several consecutive lots. All
product produced on positive lines may be held pending laboratory results.
7. After the predetermined number of lots has tested negative for L. monocytogenes,
the plant may resume its regular regime of environmental and product sampling.
8. The establishment should document the reason for contamination and steps taken to
prevent future incidents.
Page 7
establishment history. Establishments can base their sampling frequencies on any
validated statistical sampling program that achieves their objectives.
Products that have direct exposure to the establishment's processing environment after
a kill step is applied may be at greater risk from environmental contaminants than a
product cooked and distributed in the same packaging. An establishment may want to
increase the frequency of sampling of the former type of products. If no environmental
sampling is taking place, more frequent product sampling may be advisable because
the early warning of a potential L. monocytogenes problem that environmental sampling
may provide will not be available. An establishment that has a prior history of
L.monocytogenes findings by either FSIS or its own sampling program may also need to
test more frequently.
Sampling should be done as randomly as possible, with all lines and shifts eligible for
selection. From the selected lot, multiple sample packages should be collected from the
beginning, various middle time points, and towards the end of the production to test a
sample representative of the entire lot. Whenever practical, intact packages should be
sent to the laboratory for analysis, as they will provide better control of aseptic sampling.
Otherwise, an establishment should aseptically collect a portion of each package and
place the sample into a sterile bag or other sterile container for shipment to the
laboratory.
Methods
Samples should be stored and shipped to laboratories using standardized procedures.
A reputable laboratory should analyze samples. The establishment is responsible for
determining the competency of the laboratory used. The laboratory conducting the
sample analyses should have properly trained personnel, suitable facilities and
equipment, a written quality assurance program that is available to all personnel, and
reporting and record keeping capabilities. Laboratory methods employed should be
AOAC approved or the FSIS L. monocytogenes method published in the Microbiology
Laboratory Guidebook, 3rd edition (Chapter 8, Revision #1, 1/12/99).
BIBLIOGRAPHY
§ "An Evaluation of the Role of Microbiological Criteria for Foods and Food
Ingredients," Subcommittee on Microbiological Criteria, Committee on Food
Protection, Food and Nutrition Board, National Research Council, National Academy
Press, Washington, DC, 1985.
§ "Choice of Sampling Plan and Criteria for L. monocytogenes," International
Commission on Microbiological Specifications for Foods, International Journal of
Food Microbiology 22(1994): 89-96.
§ "Guidelines for Developing Good Manufacturing Practices (GMPs), Standard
Operating Procedures (SOPs), and Environmental Sampling/Testing
Page 8
Recommendations (ESTRs) – Ready to Eat Products," coordinated by National
Meats Association, April 1999. (*)
§ [http://www.nmaonline.org/guifinal.pdf ]
§ "Guidelines to Prevent Post-Processing Contamination from Listeria
monocytogenes," National Food Processors Association, submitted to Dairy, Food,
and Environmental Sanitarian, April, 1999. (**)
§ "Interim Guidelines: Microbial Control During Production of Ready-to-Eat Meat and
Poultry Products," Joint Industry Task Force on Control of Microbial Pathogens in
Ready-to-Eat Meat and Poultry Products, Washington, DC, February 1999. (***)
[http://meatami.org/Guidelines_Microbial_Pathogens_299.pdf ]
§ "Microorganisms in Foods, Volume 2, Sampling for Microbiological Analysis:
Principles and Specific Applications," 2nd edition, International Commission on
Microbiological Specifications for Foods, University of Toronto Press, Toronto,
Canada, 1986.
Sources:
§ (***) American Meat Institute, 1700 N. Moore Street, Suite 1600, Arlington, VA
22209
§ (**) National Food Processors Association, 1350 I Street, NW, 3rd Floor,
Washington, DC 20005
§ (*) National Meats Association, 1970 Broadway, Suite 825, Oakland, CA 94612
Example A
Company A makes ready-to-eat salads, including potato salad, chicken salad, ham
salad, etc. for delicatessens in grocery stores. The company manufactures product in
two 8-hour shifts, 6 days a week. The third shift is reserved for sanitation. The company
targets the salad assembly area in the environmental monitoring component of its L.
monocytogenes control program. They have identified three tiers in their sampling
program: environmental sampling points, product contact surface points and finished
product testing.
They have identified 30 environmental sampling sites, including the walls next to the
preparation tables, the exterior of the mixing kettles, the mixer shaft, the drains under
the preparation tables, etc. Each week they randomly pick 15 of the 30 sites for testing
for Listeria spp.: these 15 sites are tested twice a week ("routine monitoring") before
production. Results are tracked as total number of positives over time and also by site.
When a positive is detected at any site, it is given extra attention during the next
sanitation. If the number of positives exceeds 15% (e.g., if there are 5 positives out of
30) during the week (two test periods, rolling window), or if the same environmental site
comes up positive more than 50% of the time in a month, these sites are given extra
attention during the next sanitation, and the areas are re-swabbed daily until there are
three consecutive days of negatives.
Page 9
Once this has occurred, the plant reverts to routine monitoring. If the problem is not
corrected within 5 days, the plant enters the 'trouble shooting" mode, which includes
more stringent decontamination procedures, such as disassembly and sanitizing,
fogging with sanitizers, changing sanitizers, double sanitizing, and heat treatments.
Company A also conducts routine random product contact surface testing, they have
identified 20 key product contact surfaces. Each week 10 of these are randomly
selected and tested for Listeria spp. twice a week at the end of production before
cleaning. If a positive is detected, the site is given extra attention during the next
sanitation and the site is re-swabbed. The site is tested daily for 5 days. If the site is
positive twice doing this 5-day period, the line is shut down and, if appropriate, torn
apart, taking trouble-shooting swabs during the disassembly. The product contact
surface and surrounding areas receive extra sanitation and the line is re-assembled.
Product contact surface swabs are then taken every two hours during production and all
product is placed on hold. If any swab tests positive, product from the 2-hour time
period and from each period on either side is tested for L. monocytogenes. Product that
is negative is released. Product that tests positive is destroyed, since re-processing is
not an option for this product
The company conducts random product testing of one salad product each month by
taking one package every two hours and compositing product from x packages. This
results in two tests for each shift of product. Product is tested for L. monocytogenes.
Product found to be positive for L. monocytogenes is destroyed and routine product
contact monitoring testing for Listeria spp. is conducted daily for a week, with
appropriate action taken as described for routine monitoring of product contact surfaces.
If product is found to be positive for Listeria spp., including L. monocytogenes, the
company undertakes investigations to determine the cause of the problem. The L.
monocytogenes control program is also reviewed and revised as appropriate.
Company B
Company B produces fully cooked, breaded chicken products, The company
manufactures product on three separate lines in two 8-hour shifts, 6 days a week. The
third shift is reserved for sanitation. The company's environmental monitoring
component of its L. monocytogenes control program targets the area where product
exits the fryer, is chilled and then packaged. There are two parts to this company's
program: product contact surface testing and non-product contact surface testing.
The company monitors 20 environmental (non-product contact) surfaces on a weekly
basis for Listeria spp, (routine monitoring). Whenever a positive is detected, the
company investigates to determine if the positive is an isolated incident by re-sampling
the site and by taking additional swabs in the immediate area of the positive. If there are
no additional positives, the plant considers the initial positive to be an isolated incident
and returns to routine monitoring. If additional positives are detected, the plant institutes
corrective actions, which may include a. review of the current L. monocytogenes control
program, revising GMPs, changing sanitizes, enhanced sanitation in clean areas,
employee retraining, etc. The company then monitors twice a week (enhanced
monitoring) until there are 4 consecutive negative periods, at which point the company
returns to routine monitoring.
Page 10
The company also monitors 15 product contact surfaces on each line at the end of each
shift of production every other week. For each line, 5 swabs are composited, resulting
in 3 tests per line for a shift. If a positive is detected, company investigates by re-
swabbing and testing the swabs individually, as well as by taking additional swabs in the
area. If the swabs are all negative, they return to routine monitoring. If there is a
positive, the plant institutes corrective actions, which may include intensified cleaning,
changing sanitizer, etc. The plant then takes swabs to confirm that the actions taken
have been effective. If there are no positives, the plant returns to routine monitoring. If
there are any positives, the plant escalates its corrective actions, which may include
tearing apart pieces of equipment and sanitizing, heating pieces of equipment, etc. They
would also evaluate the need to conduct finished product testing based on all the
existing evidence. This plant does not conduct any random finished product testing
because they have determined that their control program is effective and that such
sampling would serve no purpose.
Company C
Company C produces three types of semi-dry, fermented sausages. They have
established a control program for L. monocytogenes that targets processing and
packaging operations, sanitation practices and personnel hygiene. They do not have a
routine environmental testing program; there is limited random testing done in the
environment and on some product contact surfaces. The plant has elected to verify the
effectiveness of its L. monocytogenes control program through finished product testing.
They take one sample from each lot of product and test for Listeria spp. by compositing
portions of 5 samples, retaining the remainder. Product is held pending results of the
test. If there is a positive, the company tests the retained portions for L.
monocytogenes, releasing the negative lots and destroying those that are positive.
Page 11
Appendix D: Guidance for Minimizing Impact Associated with a Food
Safety Hazard in Raw Ground Meat and Other FSIS Regulated
Products
Based upon sporadic cases, outbreaks, and product recalls involving Escherichia coli (E. coli)
O157:H7, FSIS has concluded that guidance can help grinders to develop and implement
procedures that better protect public health. This guide is intended to illustrate how grinders can
avail themselves of opportunities to minimize food safety hazards associated with their
products. It does not prescribe regulatory requirements under the Federal Meat Inspection Act
(FMIA).
§ First, grinders should structure their operations in a manner that takes into account the
safety of their raw materials and their potential product safety responsibilities through to the
end user.
§ Second, grinders should realize that they are in an excellent position to implement process
and distribution controls that reduce public health concerns associated with ground beef
contaminated with E. coli O157:H7.
§ Third, there must be an emphasis throughout the production and distribution chain on
maintaining the records that are necessary to identify, trace, and retrieve from commerce
any ground beef products that may pose a threat to public health.
Grinding operations (which traditionally buy raw materials from one or more sources and sell the
processed products to others) have a primary responsibility and unique opportunity to specify
purchase requirements related to incoming raw materials, to process raw materials under
processing and recordkeeping controls designed to ensure the safety and traceability of their
products, and to distribute products to destinations in a manner such that products can be
effectively recalled if food safety hazards are identified. Putting aside any legal considerations, it
is essential that grinding operators assume that they are responsible for their products until the
products’ end use. This is especially true for grinding operators who produce products in retail-
ready packages. This guidance material, through several guiding principles and associated
detailed explanations and recommendations, is intended to identify how grinding operations can
reduce public health risk.
Page 12
Processing operations are presently required to have SSOP’s (Sanitation Standard Operating
Procedures) and a few are already required to have functional HACCP (Hazard Analysis Critical
Control Points) systems. This guidance material is specifically designed to augment these
activities, especially the development and operation of a HACCP plan 1,2. Grinding operations
not already required to have HACCP plans are encouraged to develop and implement their
HACCP plans earlier than required as soon as possible3. Although this guidance material
highlights issues associated with ground beef, the guidance can be applied to most raw
products. This guide is not intended to be prescriptive, in a regulatory sense, but rather offers
examples of opportunities to improve food safety through purchase requirements, increased
process control, and recordkeeping.
Records that facilitate trace back and trace forward are essential whenever there is an outbreak
of foodborne illness. Although grinding operators may not have access to records of the farm
sources of their raw material, or records maintained by the plants that slaughter, dress, and
bone their raw materials, they are advised to purchase raw materials from suppliers that
maintain such records. In addition, they are advised to keep records regarding the disposition of
their products to enable tracing their products forward to consumers and back to suppliers. In
instances where grinders do not control their products through distribution and retail sale, the
chain of records necessary to trace products that raise a public health concern should not be
broken. Intermediate handlers, such as distributors and wholesalers, should assume
responsibility for keeping adequate records regarding the disposition of ground beef products
that pass through their hands. The Federal Meat Inspection Act (FMIA) requires that every
person, firm, or corporation engaged in buying or selling of meat food products must maintain
records that fully and correctly disclose all transactions in its business subject to the FMIA (21
USC 642). The recordkeeping requirements are set out in Title 9, Code of Federal Regulations,
Section 320 (9 CFR 320). Grinders are advised to impress upon all intermediate handlers of
their products the importance of records that will facilitate the efficient retrieval from consumers
of ground beef products that are a public health concern.
The guide consists of two sections: Section I., Guiding Principles; and Section II., Suggested
Procedures For Grinding Operations. This material will be continually updated and made
available through the FSIS internet web page located at http://www.fsis.usda.gov. Copies of this
Guidance for Beef Grinders to Better Protect Public Health may also be requested by fax or mail
from FSIS Public Outreach, 202-720-9063; Room 1180 South Building, Washington D.C.
20250. Comments regarding this guide should be directed to William J. Hudnall, at 202-205-
0495, and fax at 202-401-1760.
Page 13
This guide is an updated version of the guidance material that FSIS made available to the public
in March 1998. It has been modified in response to the suggestions and comments by several
organizations and to incorporate some details on rework and product recall plan derived from
the guidance provided by the National Meat Association and the American Meat Institute. This
type of incorporation was discussed during the April 22 public meeting at which each of these
organizations presented guidelines along with FSIS’ guidance material. This is the first update
of the Agency’s Guidance.
These guiding principles are supplemented with suggested procedures in Section II.
A. Grinders should determine the specifications for microbial safety that are necessary to
ensure that their products will be safe and should only accept starting materials and
ingredients that meet their specifications. In developing such specifications, grinders should
consider the intended use for the starting materials and ingredients and what, if any,
pathogen reduction actions by their suppliers would be beneficial.
B. Grinders should keep abreast of new technologies and interventions that could be
introduced into their processes to help prevent adulterated products or to identify product
that is adulterated before it enters commerce.
C. Grinders should develop and implement processes and packaging procedures to maintain
or improve the microbial integrity of their starting materials in order to ensure that they
produce safe consumer products.
D. Grinders should implement controls to identify and segregate for special handling, product
that pose a greater risk of being adulterated. Alternate outlets, such as diversion to FSIS
inspected or state-inspected processors that employ a bacterial kill-step (such as cooking),
should be acquired for such products.
E. Grinders should develop and implement rework, carry-over, and lot designation procedures
that reflect an acceptable degree of product exposure (i.e., economic risk) in the event that a
health risk is identified that results in recalling product that is suspected of presenting a
potential hazard to the public.
F. In cooperation with their customers, grinders should develop and implement handling and
distribution procedures that will not compromise the safety of their ground products once
those products leave their establishments.
G. Grinders should develop a system of records, which fits into a farm-to-table continuum, that
will facilitate trace back to the suppliers and trace forward to the distributors in the event that
a public health risk is identified.
H. Grinders should consider both the intended use of their product (hotel, restaurant, institution,
or home setting) and the most vulnerable potential user; and should provide information and
education aimed at minimizing the potential for foodborne illnesses at the level of the
ultimate consumer. Moreover, such information and education can help to assure
consumers that product found to have E. coli O157:H7 can be made safe by thorough
cooking. Steps are available to ensure that product presumed or known to have E. coli
O157:H7 is made safe as opposed to destroying it.
Page 14
Section II. Suggested Procedures for the Guiding Principles
§ Develop purchase specifications to ensure receipt of safe and wholesome incoming raw
materials. Purchase specifications should take the end use of the product into consideration.
For example, purchase specifications for raw materials for processing products with
potentially high risk end use, such as raw patties, should include either:
2. supplier operation under HACCP plans with critical control points (CCP’s) that address
pathogen intervention or anti-microbial programs, such as hot water rinses, acid spray,
steam pasteurization, or irradiation*.
*The Food and Drug Administration amended its regulations to include use of a source of
radiation to treat refrigerated or frozen meat in December 1997. FSIS is currently preparing
rulemaking on procedural and labeling requirements.
§ Examine condition of transport for sanitation-related and other product handling concerns,
including:
1. Note and document species identity, origin, age and temperature of both refrigerated
and frozen materials, supply source, boning date/slaughter date.
2. Conduct organoleptic examination (appearance, smell, any defects or abnormalities).
3. Check integrity of immediate container, protective covering, or other packaging materials
used.
4. Document type of raw materials [e.g., trimmings, cheek meat, finely textured product,
and product resulting from advanced meat recovery systems, and other comminuted
products which have undergone additional handling and processing].
5. Verify that all units are appropriately marked or coded for trace back purposes.
§ Identify and separate incoming material according to the potential risk of the product’s end
use. Small mass products such as raw beef patties are "higher risk" because they are thin,
are cooked for a short time, are preferred not fully cooked by some consumers, and the
internal temperature is not easily obtained. Large mass products such as meat loaf or chili
are "lower risk" because they are denser and are cooked evenly for a longer time. Ready-to-
eat (RTE) products such as cooked beef patties are "lower risk" because these are
subjected to a processing step lethal to pathogens.
§ Affix grinding operation’s code after acceptance of raw materials for tracking purposes.
Page 15
Storage of Raw Material (Guiding Principle C)
§ Develop storage schedule for incoming materials to facilitate product identification and
inventory control and to maintain package/pallet integrity. Raw materials can be rotated
using a First In-First Out (FIFO) system or a plant specified product rotation/inventory control
schedule.
§ Determine which units will be refrigerated or frozen, and for how long.
§ Provide ample spaces between boxes or pallets to allow for air circulation.
Grinding Process including weighing, coarse grinding, blending, mixing, final grinding,
and forming (Guiding Principles C, D, E)
§ Observe and record pre-operational and operational SSOP conformance, including those for
equipment, floor, ceilings, walls, and employees. Adopt testing (e.g., microbial, ATP
bioluminescence) to measure effectiveness of SSOP.
§ Develop a lotting or sub-lotting system for coding and tracking purposes. Assign lot numbers
that will enable tracking lot to the raw material source up to the finished products. Lotting
can be based on a full day’s production or production from clean-up to clean-up. All lots
produced between clean-ups would be implicated in any public health-based action (e.g.,
recall) unless based on the specific circumstances, the problem can be restricted to a
subset of the plant’s production between cleanups.
§ Separate processing of meat into lower risk and higher risk categories. Separation can be
by processing lines, lots, shifts, or production day. Large processing plants may be able to
use different processing lines for different categories. In small plants, the categories can be
separated by shifts or lots, in which case, processing of "lower risk" raw materials should
always precede "higher risk" raw materials.
Separation of raw materials into these two categories (i.e. lower risk and higher risk)will
prevent possible cross contamination among products with different handling history.
1. RTE product such as fully cooked beef patties. RTE processing incorporates a kill-step
such as heat processing, or cooking to eliminate pathogens including E. coli O157:H7.
2. Large mass products such as meat for meat loaf or chili. This diversion will help ensure
adequate heat processing of the product before consumption, because these large mass
products are more fully and evenly cooked than thin meat patties.
Diverting "higher risk" meat to RTE or large mass product processing is an in-house method
to reduce the risk of foodborne illness because these products are in general, adequately
cooked before consumption. In diversifying, grinders that have no facilities for processing
RTE products need outlets for their "higher risk" products. Grinders should obtain a list of
federally- and state-inspected establishments that can process ground beef RTE products.
Page 16
§ Monitor and record temperature of the meat and the processing room during the whole
operation.
1. Estimate the amount of meat for the production shift or day, so that the amount of carry-
over or rework (excess raw materials at the end of the production period that are not in
final product form) is minimal, or there is no rework at all.
2. If rework is unavoidable, use only rework meat from the immediately preceding lot or
shift, and not more than the past 24 hours. Controls should be instituted to prevent this
practice from incriminating a whole week’s or month’s production if a food safety hazard
is identified.
3. Include all rework with "higher risk" meat and process at the last shift or the end of the
production day; or divert to RTE product processing.
4. Develop a recording system for rework that includes the time, quantity, area and
processing step it was collected from, the original lot or batch number/code, and the
code of the lot or batch it was added to or included in.
§ Maintain a record of source, handling, and amount of outside trimmings added (i.e.,
trimmings not from the same batch or lot as the rest of the raw materials)
§ Monitor the time and temperature of finished products, e.g., freezing of beef patties.
§ Test for E. coli O157:H7 at any point during the grinding operation. To reduce the risk of a
recall, hold the product until the test results confirm that none has been detected. FSIS
Directive 10,101.1 on Microbiological Testing Program for Escherichia coli O157:H7 in Raw
Ground Beef sets out instructions for sampling ground beef that take into account industry
action to reduce the presence of E. coli O157:H7. FSIS has instructed inspection program
personnel that (unless otherwise directed) they are not to collect samples at an inspected
establishment which makes only raw ground products that are tested daily for E. coli
O157:H7, that are made from boneless beef lot which is certified to have tested negative for
E. coli O157:H7, or that are made from carcasses which are subjected to a valid pathogen
reduction intervention, the effectiveness of which is routinely verified and confirmed by
testing, so long as no sample has tested positive for E. coli O157:H7, in the past six months.
§ Testing may help to determine whether to divert to other products. Because of the low
incidence of E. coli O157:H7 in meat, testing is not a guarantee of the absence of the
pathogen, and the amount and frequency of sampling from different volumes of meat being
processed will vary. The point of sampling, whether raw material or the finished product, will
also vary, depending on the condition of the raw material, whether there was previous
testing, the system of controls in the plant, and the type of finished product.
§ Monitor temperature or frozen condition of finished product during the packing operation.
Page 17
§ Monitor finished product package integrity (seal, durability).
§ Monitor and record the temperature of the refrigerator/freezer and the product during
storage.
§ Include production code and sell-by-date on package label, in addition to the required
handling statement and safe handling instructions.
§ Develop and maintain an inventory control schedule for products in storage. The FIFO
inventory control schedule could also be used at this point.
§ Develop recommendations for distributors concerning the safe handling, distribution, and
coding of the finished products.
§ Maintain and record product temperature and package integrity during loading, unloading
and holding of finished products.
§ Separate and divert to "higher risk" any product that was returned after having left the plant
and been out of the control of the plant.
§ Develop an in-house recall plan to test the efficiency of the plant’s recording or coding
system. Conducting product recovery drills (mock recalls) regularly can determine and
assess the ongoing effectiveness of the recall plan. A practical and effective recall plan that
is understood by all employees should contain the following elements:
The following information should be given to regulatory authorities and press: product name,
product brand name, product codes, reason for the recall, areas of distribution, contact person
within the company.
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§ Develop a recording or coding system so that each shipping container or a retail-ready
package of ground beef has trace back and trace forward codes.
A coding system could be as simple as indicating the shift, date and production line. For
example, a code of 1/020898/2 would mean produced on ‘first shift of February 8, 1998, line
2’. Corresponding records of all incoming products used on February 8, by shift and line,
would enable full trace back to sources. These codes should facilitate tracking or trace back
to the farm source, slaughter plant, and boning plant; a determination whether the meat was
reconditioned, had intervention treatment, or had rework meat added to it; and a
determination of the dates of slaughter and fabrication, lot number, storage, and transport
records.
Thorough recordkeeping, including tracing back and forward, will facilitate recall efforts. This
will make possible rapid identification of sources of microbial contamination leading to
containment of any product that could result in foodborne illness and public health
implications. This will minimize the economic impact of recalls on affected plants, by
narrowing down implicated products to a certain lot or production code.
§ Grinding plants that have developed programs to educate their employees, distributors, food
handlers, and consumers of the risks of foodborne illness associated with the production of
ground beef products should continually monitor and update their programs. If needed,
training in the language understood by food handlers and other employees should be
provided.
§ Grinding plants without such programs should develop training and educational programs
for employees, distributors, food handlers, and consumers on the microbiological risks that
may be associated with ground beef products, and on measures to prevent foodborne
illness. Training in the language understood by the people concerned should be provided, if
necessary.
§ Safe handling instructions are currently required on the labels of not-ready-to-eat products
when distributed to consumers, hotels, restaurants, or similar institutions [9 CFR 317.2(1)].
Grinding plants should include handling information on products distributed between
establishments.
§ Grinding plants should include cooking instructions that are targeted to the specific
purchaser (e.g., product distributed to institutions with elderly, young, or
immunocompromised populations should include more rigorous cooking and handling
instructions than those provided for the general population).
A list of already developed free materials that may aid grinding plants in training and education
may be ordered by mail or fax from the FSIS Public Outreach and communications Office at
(202) 720-9352 or FAX (202) 720-9063. Many free educational materials are also accessible on
the FSIS web site http://www.fsis.usda.gov. Other educational and training materials are also
accessible via USDA/FDA Foodborne Illness Education Center at:
http://www.nal.usda.gov/fnic/foodborne/foodborn.htm .
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For Further Information Contact:
FSIS Food Safety Education and Communications Staff
Room 2932-South Building; 1400 Independence Ave. S.W.
Washington, D.C. 20250
Phone: (202) 720-9352
Fax: (202) 720-9063
Footnotes:
1. USDA, FSIS (1997) Generic HACCP Model for Raw, Ground Meat and Poultry Products, HACCP-3
2. USDA, FSIS (1997) Generic HACCP Model for Beef Slaughter, HACCP-13.
3. Federal Register: January 30, 1998 (Volume 63, Number 20) p. 4622
4. Taylor, M. (1994) Change and Opportunity: Harnessing Innovation To Improve The Safety of the Food Supply.
Speech given at the American Meat Institute Annual Convention, San Francisco, California, September 29, 1994.
Texas Food Industry Association v. Espy, 870F.supp.143,149,(W. D. Tex.1994)
5. Buchanan, R. L., and Doyle, M. P. (1997) Foodborne disease significance of Escherichia coli O157:H7 and other
enterohemorrhagic E. coli. Food Technol. 51(10): 69-76.
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